McDonald’s Pushes Dangerous Vaccinations On School KidsKurt Nimmo Infowars.com August 30, 2011In addition to pushing junk food – chock full of saturated fats, hydrogenated fats and refined sugar – McDonald’s is now pushing dangerous vaccinations on school kids, as the photo below sent by an Infowars.com reader reveals. The corporate propaganda effort is called “Immunize for healthy lives” (sic) and is set to coincide with the start of a new year of government indoctrination at public schools.

District officials have opened clinics in 48 public schools to provide free vaccinations to the 1,190 students who have yet to receive their shots or provide up-to-date immunization records. The number of students either without the shots or the updated records is about 2 percent of the school system's 60,799 students.

The biggest problems are in the middle, junior and high schools, which have 884 of the 1,190 students, Ralph Neal, assistant superintendent of D.C. schools, said Tuesday. Among those students, 614 are in the senior high schools and 270 are either in the junior highs or middle schools. D.C. officials estimated about two weeks before the Sept. 1 start of school that roughly 5,000 students were out of compliance. They have since reduced that number, in part, by working with the city's Department of Health to open the clinics.

Mr. Neal said the clinics will remain open until Wednesday and that principals were told to notify parents or guardians by phone and letters to get shots for their children. The principals also were told to send school counselors to homes in which students have not received the shots. Vera Jackson, a spokeswoman for the D.C. Department of Health, said the clinics are not getting as many students as expected, and she urged families to take action. "We continue to encourage parents to take their children to the doctor for their shots or return the [signed] consent form to the school nurse," so that students can be immunized, Ms. Jackson said.

Mr. Neal said the school system continues to follow the policy of "No Shots. No School," and that students without shots are not supposed to attend classes. The District has had a similar problem in previous years and has tried several ways to resolve it, including the threat of a $500 fine and 10 days in jail for parents of children without shots. In December 2001, about 6,000 students were without the shots and were sent home for 10 days. Only three students returned without proof of being vaccinated. The parents were charged with violating the law, but additional details were unavailable because the court records were closed. "We're better off than we were three years ago," Mr. Neal said. "I am pleased -- but not as pleased as I would like to be. Some of my parents haven't taken advantage of immunization [clinics] prior to the beginning of school. ... Parents should assume responsibility to make sure their children visit their health care provider before school begins so that we don't have 1,190 students out of compliance."

The required shots are DPT (for diphtheria, pertussis and tetanus), OPV (oral polio vaccine), MMR (measles, mumps and rubella), HIB (haemophilus influenza type B), HepB (hepatitis B), and varicella immunizations, if students have not had chicken pox. Public school officials in Prince George's County, with a student population of more than 139,000, and Montgomery County, with a student population of about 141,000, said they have no major problems with student immunizations.

"We have [immunization] clinics scheduled before school begins," said Judith Covich, a senior administrator for Montgomery County's Department of Health and Human Services. "And we get the word out in a variety of ways -- through the media, an immunization-information line and we have an International Student Office [that includes] a school health services center." She said the center immunizes students from other countries or those returning from outside the United States. Ms. Covich said nurses who work for the county's Department of Health and Human Services review records and work with parents to ensure children not in compliance are sent to a clinic. "We've been very successful," she said. Barbara Hunter, executive director of Information and Outreach for the Alexandria public school system, said student immunization is not a problem for the 11,000-student population. "We have never had the level [of noncompliance] that D.C. experiences," she said.

This spring break you and your children do not have to travel far or spend a lot of money to have a great time. The New Mexico Department of Health and several community partners are holding a spring break Movie Mania day Wednesday, March 26, at Telshor Cinemas, 2811 N. Telshor Blvd.

Children 18 years and younger and their parents will get into the new Dr. Seuss movie, "Horton Hears A Who!" with their child's shot record. The first 500 children will also get free popcorn and their choice of water, fruit punch or lemonade. The doors will open at 9 a.m. and movie showings start at 9:30 and 10:30 a.m.

"Movies touch everyone's lives and family movies like this one bring in a lot of people from the community. That's why we thought that this event would be a great partnership," said Russell Allen, vice president of operations for Allen Theatres, a co-sponsor of the event.

Not up-to-date on your children's immunizations? The Department of Health will have an immunization clinic on-site.

"Children can get free shots at the movie theater," said Liz Castro, outreach office coordinator for the Department's Office of Border Health. "They need to have a parent with them and they also need their immunization card."

The free movie event and immunization clinic are in celebration of National Infant Immunization Week, which is being held April 19-26 this year. The event is being sponsored by Allen Theatres, Las Compañeras, First Step and Memorial Medical Center. "We are celebrating a month early," Castro said. "We thought that it would be a special treat for the kids if it coincided with their spring break."

National Infant Immunization Week is an annual observance aimed at educating parents about the importance of protecting their infants from vaccine-preventable diseases. The Department of Health would like to see all of New Mexico's infants and children fully immunized.

"Because of the effectiveness of vaccines in the United States, parents are often unaware of the serious and life-threatening diseases that their children are at risk of contracting," said John Hartoon, disease prevention program manager for the Department of Health in Las Cruces. "Keeping your child up-to-date on all of their immunizations is the best way to protect them."

"Horton Hears A Who!" is based on the Dr. Seuss book of the same title about Horton, an elephant, who hears a voice on a speck of dust floating in the air. Horton, voiced by Jim Carrey, realizes that an entire world lives on this speck and vows to save the Mayor of Who-Ville, voiced by Steve Carell, and his community. The film teaches children that "a person's a person, no matter how small!"

"At Allen Theatres, when we donate to the community, it's all about helping kids," Allen said. "We think this is an excellent program for our community."

For more information about the upcoming Movie Mania event, log onto the Department of Health's Web site at www.healthynm.org.

Katie Smoker writes for the New Mexico Department of Health. She can be reached at katie.smoker@ state.nm.us. YEAH JIM CARREY!!!!!!!!!!!!!!!!!!!! JIM CARREY HALTS "HORTON HEARS A WHO" VACCINE CAMPAIGN

Jim_and_jennyBy Lisa Ackerman

Horton Hears An "Ow?"

Late last week a story hit the wire about "Free movie and immunizations: Horton hears an "ow!" (HERE <http://www.lcsun-news.com/healthyliving/ci_8617396>.) What's this? A new vaccination strategy you say?

The article referenced free vaccinations at a theater in New Mexico featuring the movie "Horton Hears A Who." In case you have been in a cave under a rock for the last month, Horton's voice is none other than the amazing Jim Carrey. And if that rock still has you covered, Jim happens to be Jenny McCarthy's boyfriend. Jenny is outspoken on vaccines & vaccination safety. A theme that runs throughout her book "Louder Than Words <http://www.amazon.com/exec/obidos/ASIN/0525950117/bookstorenow18-20>" featuring the story of her recovered son, Evan.

Once word from the autism community (Who-ville in this case) got to the Carrey & McCarthy super team about this story of a New Mexico vaccination plot things got a brewing. After his morning coffee, Jim made a few calls this morning on behalf of the autism community. Following a long discussion with his representatives at Fox Entertainment -- Who-ville -- once again through Horton - was heard. The New Mexico test market of drive thru vaccines while at the movies with your children was stopped. Halted by /*Horton himself*/ because he heard "we are here, we are here, we are here!" once again.

Thank you Jim & Jenny. You continue to be amazing heroes for the autism community. (And thanks to Kevin Barry of Generation Rescue <http://www.generationrescue.org/> for the heads up.) /Lisa Ackerman is a proud parent of Jeff, a child with autism. She founded the parent support group Talk About Curing Autism <http://www.talkaboutcuringautism.org/> in November 2000 with a dozen families in the living room of her Southern California home. The group has now grown to over 8,000 families. TACA is dedicated to community building support and disseminating information about treatments most beneficial including; dietary interventions, biological treatments, and behavioral based therapies./

Cape officials agree: Whooping cough tests faulty Text Size: A | A | A By K.C. MYERS staff writer August 25, 2007 HYANNIS — Cape Cod Health Care's extensive search for people possibly exposed to hospital staff with whooping cough in June may have been unnecessary, according to federal and local officials.

Researchers at the Atlanta-based Centers for Disease Control and Prevention announced Thursday that the most common laboratory test for whooping cough is unreliable. The discovery calls into question public health officials' claims that whooping cough cases are dramatically on the rise, the CDC said.

In early June, about 1,000 patients and staff were notified that they may have been exposed to infected staff members of the oncology department at Cape Cod Hospital. Three were suspected of having the disease, which is often fatal in infants. Two staff members were later positively identified with having whooping cough, or pertussis. More than 400 people took antibiotics as a precautionary measure. Yesterday, Alan Sugar, head of the infectious disease department at Cape Cod Health Care, confirmed the tests used to detect whooping cough are often unreliable. Growing a bacteria culture taken from an infected person is the "gold standard" test for whooping cough, Sugar said.

There's only a short time period when the bacteria can be tested by growing bacteria cultures, he said.

If the disease progresses, the body's antibodies kick in and the culture will not grow. Given the difficulty

of growing bacteria cultures, laboratories often use the less reliable method.

Sugar said one of the two staff members may have received the "gold standard" test, but he couldn't remember. In the other Cape Cod Hospital case, test results contradicted each other, he said. Still, he defended the decision to treat people with antibiotics to stop the potential spread of the infectious disease, despite the possibility that prescribing antibiotics could lead to the development of drug-resistant strains of bacteria.

"If there's a good reason, you should take them," Sugar said of antibiotics.

Government officials have said whooping cough cases have tripled since 2001, but nearly half of those tests were done with unreliable methods, the CDC found.

K.C. Myers can be reached at kcmyers@capecodonline.com.

Vaccine Refusal May Cause NY to Take Children/ Price of Children First

http://www.healthmall.com/mailarticle.cfm?&id=649

Today, 77 middle-schoolers will be yanked from home and taken into custody by New York state unless their parents agree to vaccinate them for a disease usually caught by drug abusers or the sexually promiscuous. On October 10, students in Utica were sent home for failing to get hepatitis B vaccines by the state deadline. Parents were warned the children would be turned over to Child Protective Services for neglect if they were still without vaccination in 2 weeks.

"This is Hillary-Care coming home to roost in NY," said Jane M. Orient, MD, Executive Director of the Association of American Physicians and Surgeons (AAPS). President and Mrs. Clinton's 1992 campaign pledge to create the Vaccines for Children Program (VFC) was to become the first domestic policy initiative of the administration. It was designed as their first shot to pass the Health Security Act. "Their campaign to pass VFC was based on creating a false crisis by claiming that millions of children would be exposed to risk of disease without a government program."

"This vaccine is a potential death sentence for some children," said Dr. Orient. "Government studies show that children under the age of 14 are three times more likely to die or suffer adverse reactions after receiving hepatitis B vaccines than to catch the disease itself." Hepatitis B is primarily an adult disease, usually spread by multiple sex partners, drug abuse or an occupation with exposure to blood. Children are at a very low risk of exposure, unless the pregnant mother is infected.

The school district will lose a substantial amount of state funding if students do not comply with the vaccine mandate. "We refuse to let that happen," said school district physician, Mark Zongrone. "Apparently, Dr. Zongrone is more interested in protecting his employer's budget than protecting the children under his care, and Mrs. Clinton cares more about her vision of socialized medicine," said Dr. Orient.

"It's obscene to seize a child and force him to the custody of strangers just because his parents refuse medical treatment they think is unnecessary or even dangerous," said Dr. Orient. "Parents, not Mrs. Clinton's village government bureaucrats, should make decisions about their children's medical care. We urge an immediate repeal of all vaccine mandates."

Vaccines

This is a clinical research study to evaluate an investigational combination vaccine for babies 6 - 12 weeks old and ready to begin the routine vaccination series. Research site located in Fountain Valley,California.

Please see http://www.centerwatch.com/patient/studies/cat372.html.

I really can't believe they are bringing this back out.... as it's been totally eradicated in the US for more than 30 years, and now they're bringing it back to life again! This vaccine they're discussing here is a LIVE Vaccine.... Was it the Salk or Sabin vaccine that was Live back in the 40's that killed so many people?

Read the PDF file (mentioned in the article) carefully. They are saying what we could do, but are pretty much hiding it. Feds Seek Public Input on Vaccine

http://apnews.excite.com/article/20021101/D7N182PO0.html

Nov 1, 8:28 AM (ET)

By LAURAN NEERGAARD

WASHINGTON (AP) - The government is seeking public input before it decides whether to let a few dozen toddlers and preschoolers be vaccinated against smallpox, a study to test the best children's vaccine dose but one raising thorny questions about safety and ethics.

The vaccine is made of a live virus called vaccinia that can cause its own infections until the injection site scabs over, so researchers plan to keep inoculated children out of day care or school for a month. But still there is a chance that youngsters could tear off their bandages and put relatives, playmates or others at risk. There also is the question of whether it is ethical to test in healthy children a vaccine that could cause a life-threatening reaction when the children probably won't benefit from it - unless a bioterrorist attacks with smallpox.

After research oversight boards reached mixed conclusions on these issues, the Food and Drug Administration announced Thursday that for the next month it will accept public comment on whether the University of California, Los Angeles, and Cincinnati Children's Hospital should inoculate 40 2- to 5-year-olds with smallpox vaccine. They would be the first children to get the shots since routine vaccination ended in 1972.

It's highly unusual for the FDA to seek public opinion on research.

"It is a very challenging issue because there is no smallpox circulating right now," said Dr. Karen Midthun, the FDA's head of vaccine research. "There is great concern that there be a lot of safeguards for studies being conducted in children." "This is an unusual time, it's an unusual need and I think the risks are not totally insignificant," said Dr. Joel Ward of UCLA, the lead researcher. "So I think this extra care is appropriate."

Although wild smallpox was eradicated in the 1970s, officials fear that laboratory samples might have fallen into terrorists' hands. Faced with that uncertainty, the Bush administration is preparing to make vaccine available again, first to certain health care workers and later to the general public. It's a difficult decision because of the vaccine's risks. Based on studies from the 1960s, 15 of every 1 million people vaccinated will suffer life-threatening reactions, and one or two of them will die. A vaccinated person can spread the vaccine's virus by touching the injection site, then touching the eyes, mouth or someone else. If the virus spread to the eye, for instance, it could cause blindness. Someone with a weak immune system, such as an AIDS patient, could be killed.

Children once routinely got the smallpox shot, so why is new testing an issue? The vaccine has been kept frozen for 30 years. To ensure there are enough still-potent shots to go around until new ones are made, scientists are studying whether diluted doses work. Recent studies in adults suggest they do. The planned pediatric study, sponsored by the National Institutes of Health, would test those weaker doses in young children, whose immune systems work differently than adults.

"I would certainly want these trials to be conducted before I would want my child to be vaccinated," said Dr. Julia McMillan of Johns Hopkins University, a spokeswoman for the American Academy of Pediatrics. The academy has urged the government since last spring to do child studies before allowing broad access to the vaccine.

It's not just for the child's benefit, she said. The last time children were inoculated, their relatives and playmates were too, so no one knows how kids might spread vaccinia through today's unvaccinated population. Federal regulations require special oversight for research that poses more than a minimal risk to a child who won't get a significant benefit. Oversight panels and independent experts consulted by the government have said that is the case here, because children's risk of getting smallpox is so small. Still, most of those experts said the research should be allowed because it could benefit society. They did suggest changes, such as limiting inoculations to the children of people enrolled in adult smallpox vaccine studies, because those parents may better understand the risks. Fully explaining the risks to parents is crucial, many said.

"Many parents incorrectly believe that the risk of potential exposure (to smallpox) is very high," Johns Hopkins professor Dr. Neal Halsey wrote the FDA. Under current study plans, no child would be inoculated if the child or a family member has immune problems or skin diseases such as eczema that raise the risk of vaccine complications. Children who live with a pregnant woman or infant would also be ineligible, because babies under age 1 are at significantly higher risk of a vaccine-caused brain infection.

Inoculation sites would be covered with a special bandage that in adult studies proved very effective at preventing spread of the vaccine's virus. While children are known to rip off bandages, Midthun said this one is extra sticky, "very, very hard to get off."

This is a vaccine trial for a monkey, now human virus found in the polio vaccine CMV. So, they are making a vaccine to help stop the effects of a vaccine...yes that makes a lot of sense. First Appeared Thursday, 31 October '02 Healthy Men Sought for UCSF Vaccine Study UCSF researchers at San Francisco General Hospital Medical Center (SFGHMC) are looking for healthy men between the ages of 18 and 45 to participate in a clinical trial to test a new vaccine strategy for preventing cytomegalovirus (CMV) infection. CMV is a common viral infection — one of the human herpes viruses — with more than half of all adults infected. In general, CMV does not cause disease except in profoundly immuno-compromised patients such as transplant recipients or persons with advanced AIDS. However, CMV infection, when acquired by women during pregnancy, can lead to serious neurological impairment to the child and is the most common infectious cause of neurological damage in newborns. “Our strategy is to combine an anti-CMV vaccine that has been shown to reduce the severity of CMV disease in kidney transplant patients, but failed to protect against infection, with interleukin-12 (IL-12), an immune enhancing protein,” said Mark A. Jacobson, MD, professor of medicine in residence at UCSF’s Positive Health Program at SFGHMC. “Both products have been tested separately and appear to be safe, so we do not anticipate serious toxicity issues, though this will be the first time they have been used together,” said Jacobson. Everyone in the study, which opens in November at the General Clinical Research Center at SFGHMC, will get vaccine but some participants will receive IL-12 and some a placebo. Subjects will receive only one injection. An initial blood sample will be taken to screen for CMV and 11 additional blood samples will be drawn over a year. Participants will receive $50 per study visit and an additional $200 for completing the study for a total of $750. To participate, contact Doug Black, study coordinator, at 476-4082, ext. 136. More experiments on children November 2002

ATLANTA -- The recommendation to vaccinate all healthy children 6 months to 23 months old against influenza may still be years away, according to the Advisory Committee on Immunization Practices (ACIP). The influenza vaccine is now strongly recommended by the ACIP for all children 6 to 23 months old, but the ACIP appears ready to stall consideration of a universal recommendation due to missing data. Several members of the panel requested additional safety and efficacy data before considering a stronger recommendation.

But the optimal data would come from studies conducted over multiple winters, according to researchers. Because vaccination efforts have already begun for the 2002 to 2003 season, studies probably could not be started until next year, which means that consideration of recommendations would be pushed to at least 2004 for the 2004 to 2005 influenza season, explained Keiji Fukada, MD, a medical epidemiologist with the CDC.

Although the vaccine has been recommended for use in high-risk children since the late 1970s, efficacy data have come from a few clinical trials with relatively small patient populations. There have also been limited safety studies on the trivalent inactivated influenza vaccine in young children.

A study by the Kaiser Permanente Vaccine Study group, using information from the Vaccine Safety Datalink, a linked databases of five separate managed care organizations covering 3.5 million children younger than 18, found no signals of any serious adverse events except for a possible rise in visits for impetigo after vaccination. Furthermore, said Jason Glanz, MS, of Kaiser Permanente of Colorado, who presented the data to the panel, the study confirmed that no signal had been missed by the Vaccine Adverse Events Reporting System.

The study reported on the odds of a medical event one to 14 days after vaccination, considered the most likely time for an adverse event, compared with medical events 15 to 28 days after vaccination, in 8,476 children 6 to 23 months of age.

The study found 33 diagnosis codes for visits in the 14 days post vaccination, with rises in visits for uncomplicated diabetes, atopic dermatitis, renal and ureteral disorders and impetigo during days one to three. However, only impetigo was considered possibly associated. Other reasons for a second visit included upper respiratory tract infection or cold, asthma, rhinitis, dyspnea and pharyngitis.

However, the ACIP was critical of the study, saying it was unclear whether the visits were after the first or second dose of vaccination and that further analysis was needed for the possible link to renal and ureteral disorders. Jon Abramson, MD, head of the AAP's panel on infectious diseases and an ex officio member to the ACIP, said that while more safety and efficacy data would be nice to have, feasibility issues are more problematic. He pointed out that the ACIP previously recommended influenza vaccine for pregnant women based on no efficacy data.

As well, the Vaccine Injury Compensation Program (VICP) will not immediately cover the influenza vaccine, so physicians and providers who vaccinate children will not be protected against litigation. Congressional support is needed before the vaccine is added to the injury compensation table, a move that is likely in the next couple of years, according to Geoffrey Evans, MD, director of the VICP.

"Given the direction of the governing bodies, it is likely that influenza will be covered some time down the line," he said, adding that once influenza is added, it will have eight years of retroactive coverage by VICP.

In other ACIP news, discussion of combination vaccines and their potential impact on the structure of the childhood immunization schedule has been pushed to a future meeting, possibly in June. The original agenda included discussion of combination vaccines, but the ACIP was asked in late September to strengthen its recommendations on smallpox vaccine use, precluding all other topics.

As a result, it is unlikely that new combination vaccines will be added to the 2003 childhood immunization schedule due out in January, even if they are approved by the FDA in the interim.

More experiments on children:

http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc1202.htm

[amednews.com] HEALTH & SCIENCE

Prudent to test smallpox vaccine in kids? Naysayers worry about the safety of even the diluted version on today's children; proponents say testing is warranted before widespread vaccination is deemed necessary. By Susan J. Landers, AMNews staff. Dec. 2, 2002. Additional information Washington -- The Food and Drug Administration sought public opinion on whether to proceed with a trial to vaccinate young children with the smallpox vaccine and the public responded.

Within a few days of the FDA's Oct. 31 notice in the Federal Register, hundreds of people -- physicians, mothers, fathers and preschool operators among them -- voiced opinions. Many implore the FDA not to test the vaccine, which is known to have serious side effects, on children. "Children's bodies and minds are still fragile and growing," writes one woman. "Please do not place young children in jeopardy by testing this vaccine on them." But others offer a different opinion: "Government should proceed with these tests. Smallpox vaccines should be made available to everyone." The FDA is proposing to test the vaccine on 40 children ages 2 to 5, a population that had routinely received the smallpox vaccine until it was discontinued in the early 1970s. The trial would test the safety and immune response to the smallpox vaccine, Dryvax, used at full strength and also diluted at a one-to-five ratio.

The CDC says for every 1 million smallpox vaccinations given, 1 person would likely die.

Although he didn't weigh in with an opinion to the FDA, Samuel Katz, MD, professor of pediatrics at Duke University, Durham, N.D., favors proceeding with the trial. "I think it's very appropriate that any new vaccines that will be licensed for widespread use be tested on children." Children may respond differently than adults as they might to any other pharmaceutical product, he said.

Even though the vaccine is the same one used 30 years ago, the diluent used to prepare the dry vaccine is different, Dr. Katz pointed out. The trial would also include a more diluted form of the vaccine, making it an agent that should be tested in children to determine whether it causes any unusual reactions and to find out if it produces the appropriate response. The diluted version has already been tested in adults and found to be safe and to have produced the desired result -- a raised blister that scabs over.

"I think it would be unethical not to test children," said Dr. Katz.

Several physician groups, including the AMA and the Infectious Diseases Society of America, where Dr. Katz serves as a liaison to the Centers for Disease Control and Prevention, have advised against initiating a broad vaccination campaign before there is any evidence that the disease has made an appearance. A dangerous vaccine

Potential adverse reactions from the smallpox vaccine range from fever to tissue necrosis and extensive lesions to encephalitis. A likely death rate of one per 1 million vaccinations was established by the CDC. Many predict that the vaccine carries even more dangers to today's population, which includes many whose immune systems are suppressed because they have received organ transplants, are taking cancer drugs or have HIV.

Children vaccinated for smallpox would have to stay out of school or day care for the next 30 days.

Eczema, which seems more prevalent among children today than in the 1960s, also places children at greater risk from eczema vaccinata, a rampant infection that can be contracted either from the vaccine itself or from someone recently vaccinated. Because of the risk of person-to-person transmission, children who receive the vaccine would be excluded from day care or school for at least 30 days following vaccination, according to the protocol. The vaccination would be administered to children via five skin scratches with a bifurcated needle, in contrast with the 10 to 15 scratches received by adults. The vaccination site would then be covered with a semi-occlusive dressing.

If any children should develop severe adverse events, treatment would be provided with vaccinia immune globulin and cidofovir. The latter drug, noted the protocol, has been approved by the FDA but not to combat adverse smallpox vaccine events. The final determination on whether to proceed with the trial will be made by Dept. of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan, MD, PhD.

WSJ is subscription only Thanks to Michael Belkin

Pretty amazing quote from Offit - it must be REALLY bad! ""There is no vaccine with comparable risks," says Paul Offit, chief of the infectious-diseases section of the Children's Hospital of Philadelphia. He is also a member of an advisory committee to the Centers for Disease Control and Prevention, which has posted decades-old photos on its Web site of babies and children with inflamed skin lesions (http://phil.cdc.gov/Phil/search.asp). "I would never give that vaccine to my children because right now there is no disease out there," he says.

thanks to Michael Belkin

NIH Awards $22.5 Million To Develop Anthrax Vaccine

By MARILYN CHASE Staff Reporter of THE WALL STREET JOURNAL

The National Institutes of Health awarded $22.5 million in contracts to speed development of a new streamlined anthrax vaccine, expected to start human-safety studies by May. The contracts went to VaxGen Inc. of Brisbane, Calif., which is a maker of genetically engineered vaccines, and to a closely held British maker of chemicals and protein pharmaceuticals, Avecia, of Manchester, England. The new vaccines aim to produce immunity in three doses, rather than in six doses over 18 months, as required by the current anthrax vaccine made by Bioport Inc., of Lansing, Mich.

The vaccines will use genetically engineered copies of a key anthrax protein -- known as recombinant protective antigen, or rPA102 -- to stimulate the body to create immunity against the lethal bacteria. In last fall's anthrax letter attacks, 22 people became ill. Of those people, 11 developed skin infections and another 11 the more lethal inhalational anthrax, of whom five died. Genetically engineered anthrax vaccines have protected monkeys from aerosol exposure to the deadly bacteria. VaxGen said its anthrax vaccine will license techniques pioneered by the U.S. Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md. Avecia will also use the rPA102 protein, made by a different technology.

For more health coverage, visit the Online Journal's Health Industry Edition at wsj.com/health, and take a tour of the edition. The grants from the National Institute of Allergy and Infectious Diseases, a unit of NIH, aim to speed development. The contracts require the delivery of pilot doses, and a manufacturing plan for producing more than 20 million doses, by 2003. In 2004, the U.S. Department of Health and Human Services will award larger competitive contracts to companies for the manufacture and maintenance of a 25 million-dose stockpile of anthrax vaccine.

In a speech in San Diego last week, Anthony S. Fauci, director of NIAID, said that the new paradigm of federal biodefense grants stresses the urgency of product delivery over science-for-its-own-sake. "Come back with drugs and vaccines," Dr. Fauci said. As of 4 p.m. in Nasdaq Stock Market trading Thursday, shares of VaxGen rose 13%, or $1.17, to $10.17.

(A good case for home school) "Ow," says Denae Woods, 15, a sophomore at Westwood High School in Mesa as Firefighter Steve Ward gives her a tetanus shot during a mock bioterror drill held Thursday as a practice session for emergency crews.

By Jonathan Sidener The Arizona Republic Nov. 22, 2002

Officers with assault rifles and paramedics armed with hypodermic needles invaded Mesa's Westwood High School on Thursday. The men and women in uniform were part of a daylong drill at the school to see how ready health, emergency and military systems are to deal with a bioterror attack. But the mock attack also helped provide a day of distraction for Westwood students. Some got breaks from class to participate in the drills. Others stared at the onslaught of TV satellite trucks and emergency vehicles surrounding the gym. Several football players on the way to practice were particularly enthralled with the officers' combat weapons. The bioterrorism training began at 9 a.m. as paramedics and public health nurses began dishing out tetanus shots to students. Slightly more than 3,000 students from Mesa's six high schools, including 500 at Westwood, received the free shots.

Students knew they were getting shots they needed by January, but unless they read about it in the newspaper, they didn't know they were contributing to national emergency planning. "They just told us we needed tetanus shots," student Tracy Theriot said. While emergency officials routinely conduct mock drills, the opportunity to immunize thousands of students added realism this time around, said Mary Cameli, deputy chief of the Mesa Fire Department.

"We've done many of these on the tabletop, but the chance to do it hands-on is the best," Cameli said. "We had some kids faint and some signs of anxiety, things we wouldn't have seen if we weren't giving real shots." In the drill immunizing students, emergency workers discovered bottlenecks when the paperwork went faster than the needlework, Cameli said. On the one hand, giving shots to 3,000 students in two hours is an accomplishment, she said. But it's still a small sample of the number of people who might need inoculation in a real emergency.

Wednesday, the Centers for Disease Control and Prevention in Atlanta sent a shipment of mock antibiotics to Tucson from one of 12 secret locations that make up the National Pharmaceutical Stockpile. Thursday morning, emergency workers in Tucson unpacked and sorted the labeled, but empty, pill bottles. Some bottles remained in Tucson for a drill there today. A team of Department of Public Safety officers escorted the supplies to Mesa. Wearing flak jackets, combat boots and helmets, they guarded the cargo until it was carried into the gym.

Volunteer "victims" went through a medical screening process and waited to meet with one of the pharmacists, who dispensed the fake antibiotics from Tucson.

Mostly, they waited.

Christine Mahon, of the Maricopa County Public Health Department, said the afternoon drills had also turned up some bottlenecks. Officials will look for ways to smooth out those areas in case of a large-scale crisis. We're testing our process," Mahon said. "If we can do well with hundreds of people, then we could do well with thousands."

WASHINGTON (Reuters Health) - Attorneys for the Bush Administration asked a federal court on Monday to order that documents on hundreds of cases of autism allegedly caused by childhood vaccines be kept from the public. Department of Justice lawyers asked a special master in the US Court of Federal Claims to seal the documents, arguing that allowing their automatic disclosure would take away the right of federal agencies to decide when and how the material should be released.

Attorneys for the families of hundreds of autistic children charged that the government was trying to keep the information out of civil courts, where juries might be convinced to award large judgments against vaccine manufacturers. The court is currently hearing approximately 1,000 claims brought by the families of autistic children. The suits charge that the measles-mumps-rubella (MMR) vaccine, which until recently included a mercury-containing preservative known as thimerosal, can cause neurological damage leading to autism.

Federal law requires suits against vaccine makers to go before a special federal "vaccine court" before any civil lawsuit is allowed. The court was set up by Congress to speed compensation claims and to help protect vaccine makers from having to pay large punitive awards decided by juries in state civil courts. Plaintiffs are free to take their cases to state courts if they lose in the federal vaccine court or if they don't accept the court's judgment.

The current 1,000 or so autism cases are unusual for the court. Because it received so many claims, much of the fact-finding and evidence-gathering is going on for all of the cases as a block. Monday's request by the Bush Administration would prevent plaintiffs who later go to civil court from using some relevant evidence generated during the required vaccine court proceedings. Plaintiffs' attorneys said that the order amounted to punishment of the families of injured children because it would require them to incur the time and expense of regenerating evidence for a civil suit.

"Wouldn't it be a shame if at the end of the day our policy would be to compensate lawyers," said Jeff Kim, an attorney with Gallagher Boland Meiburger & Brosnan. The firm represents about 400 families of autistic children who received the MMR vaccine. Kim accused the government of trying to lower "a shroud of secrecy over these documents" in order to protect vaccine manufacturers, who he said were "the only entities" that would benefit if the documents are sealed.

While federal law clearly seals most documents generated in individual vaccine cases, it has never been applied to a block proceeding like the one generating evidence in the autism cases. Administration lawyers told Special Master George Hastings that they requested the seal in order to preserve the legal right of the Secretary of Health and Human Services to decide when vaccine evidence can be released to the public.

Justice Department attorney Vincent Matanoski argued that to let plaintiffs use the vaccine court evidence in a later civil suit would confer an advantage on plaintiffs who chose to forgo federal compensation. "There is no secret here. What the petitioners are arguing for are enhanced rights in a subsequent civil action," Matanoski said of the plaintiffs. "They're still going to have unfettered use within the proceedings." Hastings would not say when he would issue a ruling on whether to seal the court documents, but did say that his decision would be "very prompt Regular readers of the E-news bulletins will have followed the saga of the MMR vaccine and the potential link to autism. Despite the concerns of parents, which has seen take-up levels fall to a new low, doctors are pressing ahead with plans for a new multi-vaccine to be given to babies. The new ‘supershot’ will fight up to six separate illnesses, and the current MMR jab may also be extended to cover chickenpox. Aside from the concerns about autism, this new vaccine also raises a number of other worries. Primal health researcher and WDDTY panelist Dr Michel Odent has been studying the impact of multiple vaccines on an immature immune system, both in the immediate term and right through to adulthood. He is concerned that an immune system, compromised at such an early stage, could herald a range of systemic and chronic conditions of adolescence and adult life, such as asthma and arthritis, which have reached pandemic levels. But if UK health officials are that unfazed by the autism concerns, they’re unlikely to be losing too much sleep about Dr Odent’s research. Hepatitis A - Creating a Market for Another Superfluous Vaccine By Dr. Tim O'Shea

Part 1 of 2

They finally did it. After years of lobbying and angling, GlaxoSmithKline finally got their new vaccine for Hepatitis A tacked onto the mandated schedule as of Jan 2002, with no public fanfare. (www.aap.org) The vaccine is called Havrix, and is delineated on p.1544 of the 2002Physicians Desk Reference, which incidentally was printed much earlier lastyear. Merck also has a hepatitis A vaccine - Vaqta. The CDC's mandated schedule is the brass ring that all vaccine manufacturers are going for - approval of a vaccine can mean annual revenues of $1 billion or more, which is about what Merck pulls in for their current Hepatitis B vaccine. Hepatitis A vaccine appears in a brand new category on the mandated schedule called the 'high risk' category. The significance of this new category will soon become apparent. But before we get into that, let's take a look at Hepatitis A the disease and assess the necessity for a mandated vaccine.

What Is Hepatitis A?

As every doctor knows, Hepatitis A is an acute viral disease of the liver. Hepatitis A virus (HAV) has supposedly been isolated: "a 27-nm RNA picornavirus (enterovirus) with only one serotype..."- American Academy of Pediatrics, Dec 1996 The infectious agent is passed from human to human either through the oral - fecal route, waterborne, often from raw shellfish or dirty water blood and body secretionsHepatitis A is a mild, self limiting disease, resolving on its own with no treatment in 4-8 weeks. Most infections are subclinical, meaning that most people who get the disease never even know it because they never manifest symptoms. (Merck Manual, p 377) The journal Pediatrics agrees: "Most HAV infections in young children are asymptomatic... Clinical hepatitis occurs in fewer than 10% of infected children." This disease is so mild that 90%of kids who get hepatitis A never even know it. Even the National Institutes of Health states that:"Most people who have Hepatitis A get well on their own after a few weeks." - NIH Manual: What I Need To Know About Hepatitis A :Most cases of hepatitis A are found in Third World areas, outside the US.The question pops up: then why are we the only country in the world who recommends the vaccine on a mass scale?

That billion dollars hanging in the balance wouldn't be in the equation, now would it?

Diagnosis of hepatitis A is supposedly by IgM antibody. But more often, diagnosis is by symptoms alone. Symptoms Of Hepatitis A According to Merck Manual, the chief symptoms of hepatitis A are loss of appetite dark urine Hardly life-threatening situations. Jaundice may also occur, but it usually indicates the beginning of recovery. By the time these symptoms appear, the disease is no longer infectious. Unlike hepatitis B, Type A hepatitis disappears completely after acute infection, and does not contribute to chronic liver disease or to cirrhosis. It is important to note that after the patient recovers, he has lifetime immunity. True immunity.

Hepatitis A is a disease of poor personal hygiene, bad sanitation, poverty, overcrowding - Third World scenario. Even well-groomed, well-fed junkies are not high risk for Hepatitis A. They're more apt to get Type B. Medline indicates the lack of sewers in Third World locales as the biggest contributor to Hepatitis A. Again from the journal Pediatrics we find that: "The major method for prevention of HAV infections is improved sanitation and personal hygiene"

Bottom line here: Hepatitis A is not common in most of the United States.

Other Causes

It's shocking to discover that hepatitis can be caused by both hepatitis B and hepatitis C vaccines!

This fact is found in a disclaimer that GlaxoSmithKlein makes about Havrix,that it can't cure the hepatitis caused by these other 2 vaccines. So can we infer from this that Havrix itself also causes hepatitis? We don't need to infer it.

The manufacturer states it on p 1545 of the 2002 PDR: a possible side effect of Havrix is hepatitis!

Another source of hepatitis A for children is nososcomial infection. That means infants in hospital intensive care units pick it up there. We never hear about it because the new literature is leaving it out. (AAP Policy Statement, 1996)

So Then What's The Vaccine For?

The question arises - did we really need another vaccine beyond the 40 already mandated for school kids, and specifically did we need a vaccine for a rare disease that resolves by itself in a few weeks? To answer the first, we must ask were there any studies done which prove that the new vaccine is safe when Havrix is added to the other 40 mandated vaccines?

No, there are none.

This concept of the cumulative viral load is discussed at length in the 2002 edition of The Sanctity of Human Blood. Secondly, to substantiate the necessity for any vaccine, we must look at two criteria: incidence of disease severity

How Many Cases Really Are There?

This is tricky - research roulette. In the 2002 Physicians Desk Reference, the manufacturer of Havrix cites 13-year old studies which supposedly show the incidence of hepatitis A and state that the case death rate is six-tenths of one per cent. (p 1545) This is claiming that about six out of a thousand who get hepatitis A die from hepatitis A. It seems like a rather high death rate until one realizes that these are not US figures, but global figures, meaning that they were taken primarily from Third World countries because that's where the majority of hepatitis A is found!

So that means that these patients are trying to recover from a disease of poverty, filth, and malnutrition in an environment of poverty, filth, and malnutrition. Hardly applies in the rare instance of a patient in most of America. But these are the studies and figures that the vaccine manufacturer has used to convince the FDA that Hepatitis A is such a serious disease in the US that a vaccine is necessary.

Numbers, numbers, numbers. Different sources, different stats. From the American Academy of Pediatricians website we see only half the death rate reported by the PDR: "Mortality is rare, especially in children. The case-fatality rate has been estimated as 3 per 1000 clinical cases in the United States.." - http://www.aap.org/policy/01207.html

Looking at the true incidence of the Hepatitis A in the US is an academic artifice, a daunting challenge indeed. A standard government reference for epidemiology is Statistical Abstracts. On p 137 of the most recent edition (2000), we find that the overall incidence of Hepatitis A has been declining for the past 2 decades:

1980 --- 29.1 cases per 100,000

1998 --- 23.2 cases per 100,000 This decline is good news, and of course has nothing to do with the vaccine. The vaccine just came out. But the figures still seem a little high, don't they? On closer inspection, getting out the magnifying glass and reading the microprint footnote on that same page, we read:

"Includes cases imported from outside the United States"

Huh? 'Cases imported from outside the United States'? We're not talking Pinot Noir here. No one doubts that the vast majority of hepatitis A cases are foreign. It's a disease of poverty, filth, and malnutrition. Unfortunately in a disease which only manifests symptoms less than 10% of the time, and with the immense amount of immigration and international travel going on, there is simply no way to separate foreign from domestic origin. To further illustrate the low credibility of government figures for hepatitis A cases, we need only look at a CDC report which claimed more than 10 times higher incidence: 30,000 cases, which is about 300 cases per 100,000. (Hepatitis Surveillance Report No. 55)

That's a little different from 23 cases per 100,000. So which study is right?

Who knows? Results depend on who funded it, who wrote it, and who was responsible for verification. The truth is no one can really say with authority how many cases of hepatitis A occur in the US annually.

The Real Number Of Deaths

In an earlier part of that same reference - Statistical Abstracts, p 90 - we find that the total number of annual US deaths from all 3 types of viral hepatitis put together (Types A, B, and C) in 1998 was only 4700. Remember this 4700 also includes complications of autoimmune diseases, terminal infectious diseases, and other serious illnesses, most in communities of poverty and malnutrition, alcoholics, drug addicts - individuals of this nature. This lowest common denominator of life supposedly represents the necessity of a vaccine for all.

Looking at the PDR's global figures above - a mortality of 6 out of 100,000 - we see the usual attempt by the vaccine manufacturers to grab the credit for saving us from an already declining disease. As we learned from the Michael Alderson figures cited in The Sanctity of Human Blood (p 45), virtually every infectious disease of the past century had almost disappeared by the time vaccines came on the market. This is the perfect time to make the same claim for Hepatitis A, before it disappears completely on its own. Masterful PR in action, a la The Doors of Perception - www.thedoctorwithin.com

We may be sure that future studies on US hepatitis A incidence will show vast decreases, for which the vaccine will doubtless be given credit. Just remember the virtual impossibility of determining incidence at this time, when the vaccine is being introduced. Stats game aside, almost all sources agree that children are not the group dying from hepatitis A: "hepatitis with mortality occurs mostly in people with underlying conditions, such as chronic liver disease, and in older age groups" - http://www.aap.org/policy/01207.html

The Vaccine Itself

This is fun. Hepatitis A vaccine is made from infected human connective tissue cells.

Not kidding.

Not from just one guy, but rather each batch of vaccine is made from an infected mass of cells which had 1000 donors. (Pediatrics) Imagine that party. They are infected with hepatitis A virus, the causative vector presumed to be present in every case of hepatitis A disease. The agents are filtered, and attenuated with aluminum, formaldehyde, and phenoxyethanol - a synonym for ethylene glycol - a component in antifreeze. Someday we're gonna pay for this.......

Aluminum And Formaldehyde

Just for the sake of argument, let's make the colossally irresponsible concession that the attenuated viral agent in this vaccine is necessary to stave off the "epidemic" of Hepatitis A about to sweep through our children's bloodstreams. All right, we'll concede that unlikely situation. So do the science wizards then want to explain the additional presence of one of the most potent of all human neurotoxins and also of a well known carcinogen in this supposed life-saving elixir?

Of course I am now referring to the aluminum and formaldehyde which GlaxoSmithKline thought so vital to the composition of Havrix. (PDR, p 1544)

As Drs. Russell Blaylock and Theo Colburn have well explained, it is not just the connection with Alzheimer's that makes aluminum such a danger to human physiology. It's that aluminum can interfere with the formation, development and survival of virtually any human nerve tissue in an unpredictable fashion, beyond any timetables yet devised. (Excitotoxins, Our Stolen Future) We simply don't know.

As for formaldehyde, let's just ask how much danger of cancer is an acceptable risk in the pure, perfect blood of a newborn? Cancer occurs first in just one cell. So where are the studies that prove that this "trace" of formalin or antifreeze will not be sufficient to cause that first cell mutation that develops into cancer? Where are they? As long as we're talking about scientific probability here, let's take the discussion one step further. This single causative viral agent that has been identified for hepatitis A is a presumption. Remember - diagnosis is often by symptoms and by the presence of IgM in the blood. Viral infections are not cultured for diagnosis - it's largely theoretical. So then doesn't the isolation, concentration, and dissemination of an infectious viral agent seem at least a little presumptuous if not enormously reckless, especially when we're talking about the unformed immune systems of the newborn infant population?

That seems like a reasonable question, doesn't it?

Mass Dissemination Of An Unproven Agent

Here's the key point -- is it really necessary to introduce an attenuated infectious vector into our entire population of children in order to theoretically prevent a disease which is extremely rare in the vast majority of US communities, and getting rarer? And is self-limiting, does not contribute to chronic liver disease, and confers lifetime immunity to the ones who get it? What are we doing?

Even the manufacturer does not claim that the vaccine confers immunity, but only delay of the disease.

Thus the need for boosters.

Get the idea - if the vaccine worked, we wouldn't need boosters after 6 months or a year. Following this shaky logic, if the immunity only lasts a year, the child should get boosters every year for the rest of his life.

Now, the booster shot and the first vaccination shot are identical. So why does the first shot supposedly last for a year but the last one is going to be effective for the rest of the patient's life?? Anybody ever think of that??

The other big issue is that the Hepatitis A virus is supposedly a specific agent that has been photographed, sequenced, and catalogued, and occurs the same in every case of the disease. Classical diagnosis is by symptoms and the presence of the antibody, remember? IgM.

But acute viral liver infections can be of a variety of completely different agents and disease scenarios. To pretend that they can all be cured by the dissemination of one single type of attenuated viral agent is disingenuous at best and scientifically ludicrous, even criminal, at worst. Mass inoculat ion must be absolutely proven to be necessary, beneficial and free from side effects, or else it shouldn't even be considered. Havrix meets none of these criteria.

The New High Risk Category

The most disconcerting - make that horrifying - aspect of the new Mandated Vaccine Schedule that has just sneaked up on us will prove to be the creation of this new High Risk category, in my opinion.

As we would expect, this ingenious addition was tacked onto the program with no fanfare, no general public attention. Suddenly the most vaccinated children in the history of the world are still not getting sufficient injections, even at 40 vaccines now mandated.

So for further protection, the CDC has now created the new High Risk category that they'll christen with just 2 vaccines: Hepatitis A and influenza. Now folks, these extra shots aren't really part of the mandated schedule, but are intended for the child who needs that extra protection because he is what we doctors call 'high risk.'

Which according to the American Pediatrics Association means any child who seems to have a tendency to get colds, asthma, allergies, the flu, or is generally sick.

What percentage of kids does that include? Like, all of them?

Step right up. It's such a slick set-up. The script will go something like, well, little Johnny and little Suzie just got their regular shots, so they should be fine. By the way, Mrs. Jones, do these children have a tendency to get allergies, colds, or the flu?

Oh, they do?

Well, then the newest recommendations, just to be on the safe side, are that for extra protection for Johnny and Suzie we should add just two more shots today, while they're here. And that's the new Hepatitis A shot and the flu shot. Yes, and then they should be good for a year. Yes, all the other kids are getting the 2 extra shots. You can't be too careful these days, you know.

Who's going to argue with a rap like that? Only the most informed.

Source:Center For The Advancement Of Health Date:11/25/2002 http://www.sciencedaily.com/releases/2002/11/021125071403.htm

Stressful Feelings May Influence Vaccine Effectiveness A person's state of mind may influence the body's response to a vaccine against meningitis C, suggests new research. The findings support previous research showing a link between psychological factors and antibody response to vaccines. Researchers at the School of Sport and Exercise Sciences and the School of Medicine at the University of Birmingham in England asked 60 first-year undergraduate students to answer a battery of questions about their life events, perceived stress, psychological well-being, coping styles, social support and health behaviors. The researchers also took blood samples to measure the concentration of protective meningitis C antibodies in the students. All of the students had previously received a meningitis C vaccine as part of a recently introduced national health program.

The results revealed that a high level of perceived life stress, but not actual stress, was associated with low antibody levels. A low level of psychological well being -- feeling anxious or under strain, for example -- was also linked to low antibody levels. The antibody concentrations did not appear to be associated with the amount of time between the meningitis C vaccination and the antibody tests, the students' demographics or the students' health behaviors, however. "These findings suggest that the feeling that one's life is stressful and the experience of high levels of distress were more detrimental than actual exposure to stressful life events," write Victoria E. Burns, Ph.D., and colleagues in the November/December issue of the journal Psychosomatic Medicine.

"The association between stress and vaccination response has potentially important clinical implications," the authors conclude. "In light of our findings, it may be important to monitor subsequent antibody status, particularly in those reporting high perceived stress and low levels of psychological well being." The authors note that their research supports other studies that have found associations between psychological influences and antibody response to hepatitis B, influenza, and rubella vaccines. However, theirs is the first study to show that psychological factors are associated with antibody response to a conjugate vaccine, a vaccine type used to protect against meningitis C. Meningitis is an inflammation of the membranes covering the brain and spinal cord. Bacterial meningitis, including meningitis C, is less common than viral meningitis, but can be life-threatening. Bacterial meningitis often appears as single cases, but small outbreaks at institutions such as colleges or schools sometimes arise. In the United Kingdom, the meningitis C vaccine is routinely given to students before they enter a university, the study authors write.

Mexico more effective than U.S. at immunizing children Mexico's paternalistic approach has led to a 96% vaccination rate for children ages 1 to 4, compared with 79% of American 2-year-olds. By EDWARD HEGSTROM Houston Chronicle

MONTERREY, MEXICO - If parents here are late getting their child inoculated, a public-health nurse will come to their home, pull down the youngster's pants and give the vaccination right there in the living room. If the parents are away at work, the nurse does not wait for them to come home and give permission. Shots are given anyway, and the paperwork is left with the baby sitter. In Monterrey, like Houston, an industrial city of more than a million with large pockets of underclass, the government divides its poor neighborhoods into sections of about four square blocks each, then puts a nurse in charge of supervising parents in each area to ensure all of the children are vaccinated on time.

It is a paternalistic approach almost impossible to imagine in the United States - where privacy rights and other freedoms are highly valued and immunizations are increasingly feared - but it has proved remarkably effective: Mexico has a 96 percent vaccination rate for children ages 1 to 4, compared with an immunization rate of 79 percent for 2-year-olds in the United States.

The disparity is even greater between Monterrey and Houston, which has one of the most stubbornly low vaccination rates in the United States. In Monterrey, 98 percent of the children ages 1 to 4 are fully immunized, a higher percentage than reached by any U.S. city. In Houston, barely 71 percent of 2-year-olds are caught up on their shots. Mexico's immunization success is something Americans - particularly Texans - can cheer. Epidemics of preventable disease used to go back and forth between the two countries. That no longer happens, thanks mostly to the remarkable but unheralded improvements in Mexico and other countries in the region.

"One of the main reasons there is no longer measles in the United States is because we no longer have measles in Latin America and the Caribbean," said Dr. Ciro de Quadros, the recently retired director of immunizations for the Pan American Health Organization. Mexico, he said, has done a "remarkable" job of vaccinating its children in the past decade. Conventional wisdom says it is harder to develop a public-health system in a poor country. But Quadros notes that a wealthy country like the United States has problems of its own.

"In the United States, there are so many obstacles to vaccinations," said Quadros, a native of Brazil. "People have so many forms to fill out, and there are so many more lobbies - anti-vaccine, anti-technology, anti-everything." The differences in culture and outlook between Mexico and the United States make it difficult to compare the two systems of administering vaccinations. But there are similarities, particularly between two cities that share so much trade and human traffic.

Both Houston and Monterrey suffered from a terrible resurgence of measles more than a decade ago, and leaders in both places promised to respond by bolstering vaccine programs to ensure such an epidemic never happened again. The goal - on both sides of the border - was a 100 percent vaccination rate. But while Monterrey and Mexico as a whole have come close to keeping that promise, the improvement in Houston's vaccination program has not been so great. Vaccinations are clearly up from the winter of 1988-89, when 10 children died from measles in Houston and organizers of the Houston Livestock Show and Rodeo distributed letters warning that participants may have been exposed to the disease and risked taking it to other parts of the country.

Public and private groups responded by forming a number of programs, such as mobile health clinics, which are designed to better reach the most needy areas of Houston. But Houston still has no coordinated vaccine registry, which officials say is necessary to reach the people effectively. And the effectiveness of the patchwork services now offered by so many different organizations is hampered by a lack of any central vision for running an immunization program, critics say.

"There's no real local leadership on the immunization issue," said Barbara Best, with the Children's Defense Fund. While no one predicts another measles resurgence, officials in Houston and the rest of Texas have already started to worry about a return of pertussis, also known as whooping cough. Mexico, by contrast, has a sharply focused vision. After the measles pandemic reached Mexico in 1990 and killed 5,899 babies, the Mexican government established a central authority to oversee the national vaccination campaign, known as the National Immunization Program.

Immunization campaigns are run three times a year, done with great fanfare. In addition, uniformed brigades of nurses keep careful watch over vaccination rates, neighborhood by neighborhood. U.S. health officials, who have seen the unsparing force of a Mexican immunization campaign, tend to remember it with both awe and dread. The public-health nurses of Monterrey begin tracking babies before they are born.

The nurse in charge of immunizations in a particular neighborhood keeps a census of the area, including maps detailing where women of child-bearing age live. Babies are given their first immunizations - against polio and tuberculosis - in the hospital right after birth. They also receive a government-issued National Vaccination Record, on which the vaccines they receive throughout their lives will be tallied. The vaccine record must be presented in order to enter school, to get passports or other identification papers and even to get some jobs and loans. Losing the record is not usually a problem, because the same information is recorded with the federal government and can be replaced.

HEALTH & SCIENCE

http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsb1209.htm

Pediatricians praise pentavalent vaccine, question cost Lowering the number of injections may increase the number of children vaccinated, but experts worry that inadequate reimbursement levels could stall widespread use. By Victoria Stagg Elliott, AMNews staff. Dec. 9, 2002. Additional information Kids can expect fewer vaccine shots in the future. With the promised, year-end introduction of a vaccine to include antigens for diphtheria, tetanus, pertussis, polio and hepatitis B, doctors will be able to reduce the number of injections their youngest patients must endure in a single visit.

The pentavalent vaccine, which insiders expect to be approved by the Food and Drug Administration this month, will be manufactured by GlaxoSmithKline and is expected to be the first of an increasing number of vaccines that protect against five and even six diseases. "It's less painful for the child. It is less stressful for the medical staff that is administering the vaccine, and it's less stressful for the parent who's watching it," said Edgar Marcuse, MD, MPH, professor of pediatrics at the University of Washington, Seattle.

Experts say multivalent vaccines may increase vaccination rates and make parents more willing to let children get all the shots they need in one visit, rather than scheduling multiple appointments, which can lead to late vaccinations. "I'm excited about it," said Robert Yetman, MD, professor of pediatrics at the University of Texas Medical School at Houston. "If the number of vaccines we are currently giving patients is a reason for some parents to avoid getting their children immunized, then this will help eliminate this roadblock to improving our immunization rates." Reimbursement barrier

Vaccines with antigens for five or six diseases are already in widespread use around the world. But in the United States no currently available vaccine includes more than three. Still, as much as physicians say multivalent vaccines are a significant step in the right direction, there are many concerns that reimbursement issues may impact the number of doctors who administer the new vaccine. The cost of the vaccine may not be adequately covered by insurance.

In addition, physicians may receive less reimbursement for administering fewer injections in one visit despite the fact that the same number of antigens are being delivered to the patient. With the number of combination vaccines expected to increase significantly over the next few years, the issue is one of great concern and is expected to come up at this month's American Medical Association Interim Meeting in New Orleans. "Without reimbursement, this will not be adopted," said Gary L. Freed, MD, MPH, director of general pediatrics at the University of Michigan School of Public Health in Ann Arbor. There are also concerns that problems with record keeping combined with a mobile population may lead to overimmunization.

Children may shift from one doctor to another, both of whom may stock different combinations. Records may be incomplete or get lost. "As we get additional combinations licensed, and the combinations share common components but also have different components, it's going to increase the chance of confusion and miscommunication and make far more important the maintenance of very accurate records," Dr. Marcuse said. Children also may shift back and forth between public-sector vaccine sources and private physicians. Most believe that the public sector may be the slowest in adopting the multivalent vaccines, primarily because of cost issues. "The public sector may choose not to buy this vaccine if it costs a lot more than the individual vaccines themselves," Dr. Freed said. Also, not all vaccines included in the pentavalent vaccine are always delivered at the same time. Currently, hepatitis B is also frequently administered at birth, by itself, as well as additional doses during the visits at two and six months when it is given along with IPV, DTaP and several other vaccines not planned to be included in the five-valent mix.

"If a physician or hospital gives a child the newborn dose of hepatitis B yet wants to use this vaccine for at least a portion of the primary immunization series, they will have to be careful they don't give a child too many vaccines," Dr. Freed said. "There's no known harm to giving an extra vaccine, but we need to realize that that is a possibility." And despite recent anxieties expressed by certain vaccine awareness and parent advocacy groups over the combined measles, mumps and rubella vaccine, physicians say that most of their patients would prefer the reduction in needlesticks. "More than likely, parents will welcome the chance for the child to get fewer injections," Dr. Freed said.

The initial hope is that the multivalent vaccines will reduce the number of needlesticks kids must endure. In addition, though, many suspect it will simply make room in the schedule for new vaccines that are just around the corner. "We need to make room because there are more vaccines that will be coming, and you just can't keep giving more shots to children," said Mark Blatter, MD, medical director of Primary Physicians Research in Pittsburgh, the company that ran many of the trials on the new vaccine. "After years of increasing the number of shots, for the first time, we will be able to decrease the number of shots by as many as six."

ADDITIONAL INFORMATION: Increased protection

The first pentavalent vaccine in the United States is expected to protect against:

* Diphtheria * Tetanus * Pertussis * Polio * Hepatitis B

Vaccine topics from the FDA's Center for Biologics Evaluation and Research (http://www.fda.gov/cber/vaccines.htm)

CDC National Immunization Program (http://www.cdc.gov/nip/)Comment from the web: I'm not a medical person, but I am a person that can think. It astounds me that the doctors can believe that injecting numerous antigens (pathogens, viruses) along with an assortment of adjuvants (poisons) that the tiny immune systems can actually begin manufacturing antibodies to all of these without a misstep. It seems to me that doctors would realize how dangerous it is to do this to little babies. I think it is interesting also that so many newborns at birth have jaundice. I read that Vitamin K can overwhelm the liver and cause this. But the doctors don't know that? It is a miracle that most babies live through all these assaults on their bodies, though we know many don't (SIDS). http://www.washtimes.com/national/20021223-12520450.htmFederally funded study measures porn arousal Rep. Dave Weldon, Florida Republican, cited the Northwestern study as an example of misplaced research priorities, saying he asked NICHD three years ago to study whether the measles, mumps and rubella (MMR) vaccine was associated with autism. "The NIH couldn't find the money to look into this relationship between kids with regressive autism and the mandatory MMR vaccine, but they can pay people $150,000 to watch pornography," Mr. Weldon said. "This is disgusting, and is a clear example of distorted priorities at the NIH. The NIH message to parents of autistic children: Don't look to us for help." Alarm as GM pig vaccine taints US crops

Strict new guidelines planned after contamination

Suzanne Goldenberg in Washington Tuesday December 24, 2002 The Guardian

US authorities, shaken by a case in which food crops were contaminated with an experimental pig vaccine, are preparing to impose stringent guidelines on a new generation of experimental GM crops.

The department of agriculture and the environmental protection agency are encountering growing disquiet from a coalition of farmers and food manufacturers about the potential dangers of the next phase of GM products - "biopharming", or the implanting of genes in food crops to grow drugs and industrial chemicals.

The idea of tightening regulations on GM products represents something of a revolution in thinking in the US, where about 70% of the processed food on supermarket shelves contains genetically engineered ingredients. But concerns have arisen after a small biotech firm in Texas was fined $3m (£2m) for tainting half a million bushels of soya bean with a trial vaccine used to prevent stomach upsets in piglets.

Under a settlement reached this month, the first of its kind against any biotech company in the US, a firm called Prodigene agreed to pay a fine of $250,000 and to repay the government for the cost of incinerating the soya bean that had been contaminated with genetically altered corn. US authorities said the corn did not reach food crops or animal feed. But the episode has drawn unwelcome attention to an as yet experimental area of GM farming.

The premise behind biopharming, or "pharming" for short, is that genetic tinkering can turn an ordinary-looking corn or barley field into a potential drug factory, producing insulin, chemotherapy drugs, and other products for much less than it would cost to set up an industrial plant. At present, two dozen trials of the experimental GM drugs are under way across the US.

The biotech firms argue that the new technique can revolutionise health care, especially in the developing world where hospitals short on syringes can dispense edible drugs. But in the wake of the Texas case, questions are being asked. The latest incident was the worst violation so far of regulations intended to keep biopharming out of the food supply. It was also seen as the most serious setback to date to the next generation of GM farming.

Until now, genetic engineering has been used mainly to make crops such as corn and soya bean resistant to insects and disease, and the US food industry has been solidly on side. The Texas alarm has begun to change that. "The incident overall just reaffirms our concerns that something could go wrong," Stephanie Childs of the Grocery Manufacturers of America, which represents food companies such as Kellogg and General Mills, told the Los Angeles Times.

Analysts in Washington said yesterday that they expected the department of agriculture to impose more stringent guidelines next year. Published reports said yesterday that guidelines under consideration by the authorities include moving experimental farms away from America's grain belt in the mid-west, or requiring growers to dye the leaves of the altered crops.

The agriculture department's disciplinary measures against the small Texas firm have crystallised concerns among farmers, environmentalists and industry about the risks of experimental vaccine crops getting into the food supply.

"The department of agriculture wanted to send a signal that the companies need to take the obligation to protect the food supply very seriously," Michael Rodemeyer, the director of Washington's Pew Initiative on Food and Biotechnology, said yesterday.

"The whole issue of growing pharmaceuticals in food crops has certainly raised concern within the food industry, as well as among environmentalists and others, about genes from these crops getting into the food supply."

Journal of Gastroenterology and Hepatology 02/03/2003 By David Loshak

Standard vaccinations of specific hepatitis B antigen have failed to combat chronic hepatitis B infection in immunotolerant children with normal aminotransferase levels and high viral load.

Researchers in Diyarbakir, Turkey, report that vaccinated and unvaccinated immunotolerant children with the infection did not differ in their clearance of hepatitis B virus DNA. Nor did they differ in their seroconversion of hepatitis B early antigen to its antibody.

Fifty one children participated in this study. Twenty three were randomised to standard injections of the GenHevac B vaccine in the deltoid or quadricep muscles at baseline and at 30 and 60 days. Twenty eight children, also infected, were not given any medication or vaccination and served as controls.

Response to therapy was defined as loss of hepatitis B virus-DNA in serum and hepatitis B early antigen seroconversion (loss of hepatitis B early antigen and development of antibody to hepatitis B early antigen).

At the first vaccination, the mean alanine aminotransferase value in the vaccinated children was 33.6 ± 8.1 IU/L. It was 31.7 ± 9.0 IU/L at 6 months and 29.2 ± 7.1 IU/L at 12 months. Mean hepatitis B virus-DNA load was 3709 ± 1126 pg/mL initially. At 6 months, it was 3569 ± 726 pg/mL and at 12 months 3295 ± 832 pg/mL.

The load of hepatitis B virus DNA of all patients in both groups exceeded 2000 pg/mL.

At both 6 and 12 months, there were no statistically significant differences between the vaccinated children and the unvaccinated controls in mean alanine aminotransferase values or mean viral loads of hepatitis B virus DNA.

The researchers found no hepatitis B surface antigen and hepatitis B early antigen clearance, nor any antibody to hepatitis B surface antigen and antibody to hepatitis B early antigen seroconversion during follow-up, other than in one patient in each group.

The researchers said that other immunisation protocols should be considered for future investigations into immunotolerant children with chronic hepatitis B infection. Journal of Gastroenterology and Hepatology 2003;18:2:218-222. "Failure of therapeutic vaccination using hepatitis B surface antigen vaccine in the immunotolerant phase of children with chronic hepatitis B infection."

Again - there is NO safe vaccine. But certainly DPT is a very bad one and to keep DTaP a secret from UK people is immoral and criminal Sheri

http://www.thescotsman.co.uk/health.cfm?id=151072003

Parents must ask to receive safer vaccine

FRASER NELSON

DOCTORS have been told to come clean about Infanrix, the safer whooping cough jab available on the NHS - but only if directly challenged about it by parents. The compromise means that parents who ask no questions will have their children injected with the cheaper DTwP jab laced with ethyl mercury - a substance ordered out of US medicine on health grounds.

The deal was met with political outrage yesterday as Scotlandâ's opposition parties accused the Scottish Executive of skirting around its duty to give parents the full facts about vaccination options before going ahead. Dr Andrew Fraser, Scotlandâ's deputy chief medical officer, has written an "urgent message" to Scottish medical specialists alerting them to fears around thimerosal, a controversial vaccine preservative 50 per cent composed of mercury.

The substance is contained in DTwP, the Â£10-a-shot jab from France which protects against diphtheria, tetanus and pertussis, or whooping cough, routinely given to all babies aged two, three and four months. Its rival is Infanrix, a UK vaccine available on the NHS to the few parents who know to ask for it by name. It is almost twice the price because it comes without the so-called "junk cells" suspected of giving children fever after injection.

It is also made without thimerosal - and is the type of vaccine routinely used in the United States, Canada, Japan, Australia and South Korea. "Parents are entitled to know if thimerosal is contained in the vaccine available to them," Dr Fraserâ's letter said. "They should be aware of the reason for this - ethyl mercury is an essential component of the most effective vaccine available to protect children."

The Executive explained that this "entitlement" only extends to parents who ask if they have an alternative. Those who do not will be given the mercury vaccine. "The DTwP is recommended, because it is more effective. So that is the one which is given. If parents were to ask a question, for whatever reason, they would be told everything - about the choice, the side-effects, whatever they wanted to know."

The Scotsman revealed yesterday that babies injected with the cheaper DTwP vaccine are ten times as likely to suffer side effects ranging from fever to periods of unusual crying lasting more than an hour.

In a Holyrood debate yesterday, Frank McAveety, Scotlandâ's deputy health minister, admitted that Infanrix does have "lower levels of side effects" - but said it was less effective. "Our recommendation is that, on the balance of risk, DTwP offers the best protection against whooping cough. Each individual or family will have to make those choices in consultation with their medical practitioners."

Nicola Sturgeon, the SNPâ€™s health spokeswoman, said this is meaningless if parents are not being told that Infanrix exists. "Choice can only be exercised if parents have the information to make that choice," she said. "There will be no consultation if doctors do not pro-actively lay out the options."

Mary Scanlon, the Toriesâ€™ health spokeswoman, asked Mr McAveety to publish the performance data for both vaccines - saying that only this could let parents decide which is best for their children. The thimerosal debate has swept the US, where parents are now suing drug companies. They are fast building evidence that the ethyl mercury induced autism in their children.

Lord Hodgson of Astley Abbotts, a Tory peer, raised the issue in the House of Lords on Wednesday night, calling for ministers "to follow a long list of developed countries and remove thimerosal from vaccines forthwith". Thimerosal has not survived any public debate in any country. The Scottish Executive has said it will soon publish the figures it uses to argue that the mercury vaccine is better. Sunday Herald - 17 October 2004 Plan to make baby buggies from nuclear waste Industry in bid to recycle contaminated material By Rob Edwards, Environment Editor, and Peter John Meiklem

Thousands of tonnes of radioactive scrap metal from nuclear plants could be melted down and recycled into cutlery, saucepans and baby buggies under a scheme being promoted by the nuclear industry and its regulators. A report compiled for the government’s Nuclear Installations Inspectorate and leaked to the Sunday Herald concludes that “metal melting” is a good way to deal with nuclear waste because it would save money and be environmentally friendly.

The aim is to reduce the levels of radioactivity in metal from decommissioned nuclear facilities by mixing it with less contaminated scrap. Some of the metal could then be sold on to the open market and used to make household items. As the leaked report points out, there is only one snag – the public might not like it. “There are significant stakeholder issues that must be considered in order to implement an integrated metallic waste management strategy,” it says.

“These include public unease regarding the re-use of previously radioactive contaminated metals, and public concern over the transport of radioactive waste.” The report was written by researchers from NNC, a company in Knutsford, Cheshire, that provides services to the nuclear industry. Commissioned by the nuclear inspectorate, it was presented at an invitation-only seminar in Warrington earlier this month. It points out that there are 70,000 tonnes of medium-level and 383,000 tonnes of low-level radioactive scrap in the UK. In Scotland, this comes from nuclear plants that are being decommissioned at Dounreay in Caithness, at Hunterston in North Ayrshire and at Chapelcross in Dumfries and Galloway.

The establishment of melting plants for radioactive metal would be consistent with the government’s aim of minimising waste, maximising recycling and being environmentally sustainable, the report says. It would also “reduce disposal costs”. “The idea is to prompt people to take a more wide-ranging approach to the issue,” said NNC’s Matt Buckley, the lead author of the report. “It is hoped that this can be considered as part of a strategy by the nuclear industry.” He stressed that recycling contaminated metal into household goods was only one option. Metal melting could also help reduce the volume and radioactivity of waste, making it easier to handle and dispose of. Glyn Davies, a principal inspector with the Nuclear Installations Inspectorate, argued at the seminar that “potentially beneficial options for management of metallic wastes are not being given adequate consideration”.

“If our European friends see metal melting as a benefit and can make it work, then why not the UK?” he said. “Melting may contribute significantly to the management of metallic radioactive waste in the UK.” However Jane Hunt, an independent expert on public attitudes to nuclear waste, warned that the plan would cause a scare. “This is likely to cause a lot of public concern because people are very sensitive about radioactive contamination,” she told the Sunday Herald.

“The idea that radioactivity could be in cooking imple-ments or children’s buggies will frighten people.”

Coincidentally, the nuclear-free group of local authorities also held a conference on the issue in Hull on Friday. The group’s chairman, Dundee councillor George Regan, pointed out that some scientists thought that even the tiniest amounts of radioactivity could increase the risk of cancer. “Do you think an ordinary housewife would buy radioactive pans, even if they told her they were safe? I doubt it. I wouldn’t take the chance. The fact is that people do not want products recycled from radioactive material.”

The nuclear industry has launched a consultation on a code of practice for recycling waste that contains so little radioactivity it is “exempt” from regulation. It would expose people to only a tiny amount of radiation above background levels, the industry says. David Owen, chairman of the Nuclear Industry Clearance and Exemption Working Group, said that legislation would allow companies to recycle nuclear waste. “It is not my place to tell them what they can and cannot do. It is very important to do the right thing. We will take good ideas from anywhere .”

The government’s green watchdog, the Scottish Environment Protection Agency (Sepa), said the aim was to keep radiation doses to members of the public “as low as is reasonably achievable ”. Radioactivity should be disposed of by the “best practicable means”.

“As long as safety is assured there is a role for the re-use and recycling of radioactive contaminated wastes, and this supports sustainable development,” said a Sepa spokesman. But he accepted that there may be uses, like cooking utensils, drinks cans and children’s playgrounds, for which recycled radioactive materials could be inappropriate. “One argument might suggest that we should develop controls on products that permit some limited rather than general re-use.”

Environmental groups were less sanguine. “In a desperate attempt to cut costs, the nuclear industry has now devised one of the most potentially harmful examples of a ‘dilute and disperse’ policy”, said Duncan McLaren, chief executive of Friends of the Earth Scotland. “The idea of contaminated materials entering people’s homes is alarming. The notion that the nuclear industry has suddenly caught on to the idea of waste reduction is a nonsense. If it had, then it would stop calling for the building of more nuclear power plants.”

ANONYMOUS ALLEGATION SPARKS ALERT, LEADS TO AN OFFER OF REVACCINATIONS, WHICH POSE NO DANGER

By Matthai Chakko Kuruvila

Mercury News

The Palo Alto Medical Foundation and the MayView Community Health Center in Mountain View announced Tuesday that vaccines given to 1,275 toddlers in 2001 may not be effective, and that they are offering to revaccinate the children. The unusual public health effort is driven by an unprovable, anonymous allegation that a former clinic employee mishandled the 2001 vaccines. The employee, who no longer works for the medical foundation, told the Mercury News that she is the victim of a smear campaign.

As public health officials and the two medical centers investigated the allegation, they couldn't account for all the vaccines given to children in 2001. So they felt they had to alert parents. ``We weren't able to prove the allegations in the letter or disprove them,'' said Jill Antonides, a spokeswoman for the Palo Alto Medical Foundation. ``But we decided that the right thing to do would be to take a cautious approach.'' The medical centers are now offering revaccinations, which they say pose no danger even if children received effective immunizations.

The various vaccines given in 2001 were at worst ineffective, meaning that the children would not be immunized against a laundry list of illnesses: Hepatitis B, haemophilus bacteria, polio, measles, rubella, tetanus, diphtheria, whooping cough, pneumococcus bacteria and chicken pox. Most of the children were 1 to 2 years old in 2001, and none of them developed the diseases they were supposed to be protected against, said Dr. Marty Fenstersheib, health officer for Santa Clara County.

The investigation into the vaccines began in April, when an anonymous letter was sent to the Palo Alto Medical Foundation and the Palo Alto Police Department. The letter stated that the San Carlos woman had transported vaccines in an unrefrigerated car from the medical foundation and the MayView Health Clinic. The vaccines need to be refrigerated to be effective. Officials had no proof that she had done so, but there was enough detail to warrant an investigation, Fenstersheib said. The county and the medical centers spent months poring through thousands of records to see whether any vaccines could have been mishandled.

After finding discrepancies in some vaccine records, authorities issued the call for revaccination. The registered nurse who is at the center of the investigation said she had no idea who was sending the letters about her. But she speculated that it might be related to her pending divorce. The woman, who said she was dismissed from the medical foundation in 2003 for an unrelated matter, said she never transported vaccines unsafely. The foundation has sent letters to the parents of 1,250 children and set up an information line for questions at (650) 853-2300. The MayView center will individually contact the parents of 25 children who may have received vaccines in question. Parents also may call (650) 965-3323, extension 311, to schedule an appointment.

Both clinics have set up drop-by hours for the revaccinations, which are free of charge.

Since religious/philosophic exemptions from immunizations endanger not only the health of the unvaccinated individual, but also the health of those in his or her group and the community at large, the AMA (1) encourages state medical associations to seek removal of such exemptions in statutes requiring mandatory immunizations; (2) encourages physicians and state and local medical associations to work with public health officials to inform religious groups and others who object to immunizations of the benefits of vaccinations and the risk to their own health and that of the general public if they refuse to accept them; and (3) encourages state and local medical associations to work with public health officials to develop contingency plans for controlling outbreaks in exempt populations and to intensify efforts to achieve high immunization rates in communities where groups having religious exemptions from immunizations reside. (CSA Rep. B, A-87; Reaffirmed: Sunset Report, I-97)

Prevention of nasopharyngeal colonization may reduce the burden of pneumococcal infection during infancy. Colostrum obtained from Gambian mothers who had been vaccinated with either Pneumovax II or Mengivax A&C (n=8 per group) during pregnancy was examined for inhibition of adherence of Streptococcus pneumoniae serotypes 6B and 14 to pharyngeal epithelial cells in vitro. Pneumococcal adherence was significantly reduced in the presence of breast milk (P</=.0001 for S. pneumoniae serotype 14; P=.036 for serotype 6B), independent of the concentration of secretory IgA antibodies. Maternal vaccination with polyvalent pneumococcal polysaccharide vaccine boosts the capacity of colostrum to inhibit adherence of pneumococci to pharyngeal epithelial cells. In breast-feeding populations, maternal vaccination might prevent pneumococcal disease in young infants.

NEW YORK (Reuters Health) - A measles outbreak earlier this year was contained by instituting quarantine measures after exposed persons refused post-exposure preventative treatment, according to a report from the Iowa Department of Pubic Health and other state offices.

As described in the CDC's Morbidity and Mortality Weekly Report, local and state health departments contacted people exposed to a student returning to Iowa from India who had come down with measles. Two of these contacts caught measles, and people exposed to them were also identified. Altogether, approximately 200 persons were given post-exposure prophylaxis (PEP), consisting of measles-mumps-rubella (MMR) vaccination within three days of exposure or immune globulin within six days.

Two of the three infected people belonged to "an insular community with low vaccination rates," the authors explain. All susceptible members of the community were offered PEP, but seven individuals refused. The seven were served with state-issued involuntary home quarantine orders for two weeks. Compliance was monitored with unannounced home visits or telephone calls. "A lot of things went into our decision to use quarantine," Dr. Patricia Quinlisk, with the Iowa Department of Public Health in Des Moines, told Reuters Health.

"For example, the highly infectious nature of measles; the fact that in some of the communities a large percentage of the people were totally susceptible to measles; the fact that measles can be a serious disease, especially in adults; and that the community had large daily gatherings which would have allowed measles to be transmitted."

This episode "was sort of a dry run should something happen that is more catastrophic," Quinlisk commented. "I think it has made us more aware of how the system did work quite well in lot of ways."

An editorial note with the report points out that all states have the authority to detain persons under quarantine laws.

The authors recommend that states that have not recently reviewed their quarantine laws do so, specifically reviewing issues of quarantine authority, such as what diseases would be covered and how quarantine is to be enforced, as well as jurisdictional considerations and due process concerns.

This is a complete abuse of police powers by the health department in Iowa. They forcibly quarantined people who refused vaccination who were allegedly exposed to measles. Yes, you read that correctly – they did not have the measles – they were exposed to measles. Quarantining healthy people for an exposure to the measles when 99.9% of the people who catch the measles fully recover (according to sworn testimony at the Texas Legislature by past Associate Commissioner of Disease Control Dr. Diane Simpson who now works at the CDC) if they refuse vaccination is nothing more than harassment and an absolute abuse of powers. Laws granting health departments unchecked authority to forcibly vaccinate or quarantine someone who is not sick need to be changed. They even admit in this article that this was practice for them in case something more catastrophic happened later. If it happened in Iowa, it can happen anywhere anytime.

If you would like to work on grassroots efforts to stop this in your state, familiarize yourself with your current state statute and contact your legislators immediately asking for medical, religious and conscientious exemptions be inserted into these statutes with reasonable humane quarantines for those who are actually sick if the disease is unreasonably deadly or dangerous. In Texas, these abusive laws are contained in the Health and Safety Code, Chapter 81 called the Communicable Disease Prevention and Control Act. You can link to them by going to http://capitol.state.tx.us, clicking on Texas Statutes, Clicking on Health and Safety Code, then clicking on CHAPTER 81. COMMUNICABLE DISEASES, sections 82 and 83.

”If the department or a health authority has reasonable cause to believe that an individual is ill with, has been exposed to, or is the carrier of a communicable disease, the department or health authority may order the individual, or the individual's parent, legal guardian, or managing conservator if the individual is a minor, to implement control measures that are reasonable and necessary to prevent the introduction, transmission, and spread of the disease in this state."

In Texas and most states, as the article below points out, the health department has the authority to force the above "control measures" under suspicion of exposure. These laws are separate and apart from exemptions for school they apply to all people - adults and children - and grant the health department way too much power. There are no exemptions for medical reasons, religion or conscience from immunization for adults or children if the health department orders vaccination under this law, and this needs to be changed ASAP. It is reasonable to have someone who is ill with a contagious illness with a high rate of death and disability to remain quarantined until they are well, but to disrupt the lives and punish HEALTHY SYMPTOM FREE people refusing immunization for an exposure to the measles is intolerable and people need to fight this.

I do know that Connecticut, thanks to the great work of Lisa Reiss and CTVIA, has exemptions in their state emergency powers laws, but as far as I know, that is the ONLY state. Please get familiar with your state law and start contacting legislators to stop this unchecked potential for abuse. We need these changes in every state. - DR]

Copters to drop rabies vaccine If you find a fishy smelling chunk, it might be a bait that is designed to inoculate raccoons, but works on other animals.

By THERESA BLACKWELL, Times Staff Writer Published February 23, 2005

If the sunshine holds, fishy-smelling bait filled with rabies vaccine will rain over Pinellas County again starting this week. Pinellas County Animal Services plans to launch its annual aerial assault on rabies. The campaign began 10 years ago in response to 30 rabies cases that year. County helicopters will drop at least 20,000 rabies baits over Pinellas during a month's time. The U.S. Department of Agriculture is paying for the baits.

The main treatment area lies north of Gulf-to-Bay Boulevard and includes the Brooker Creek Preserve, the county's borders with Hillsborough and Pasco counties and Honeymoon and Caladesi islands. Officials will try to put the baits wherever there are isolated woods, said Welch Agnew, the assistant director of veterinary services for Pinellas County Animal Services.

Other areas include Weedon Island, Gandy Flats, the St. Petersburg-Clearwater International Airport, Pinellas County Utilities Solid Waste, Fort DeSoto Park and other parks south of Gulf-to-Bay. County officials say the oral vaccine program works, but it's only part of the solution to protecting residents and their pets from rabies.

"Vaccinate your pets," Agnew said. "That's the key to the whole rabies control program." Agnew said the vaccine protects your pets. It also provides a buffer zone between humans and wildlife with rabies. With the aerial vaccination program, new cases of animals with the raccoon strain of rabies went down to one animal each year in 1998, 1999 and 2000. Numbers crept up slightly in subsequent years, so the county put out an increased number of baits in 2004.

Last year, raccoons confirmed as rabid mingled with humans three times in Pinellas County, twice in Palm Harbor and once in northern Clearwater. And a rabid bat crawled up the leg of a woman at an outdoor restaurant in St. Petersburg. On Feb. 10, a rabid raccoon was found near Clearwater Christian College, north of Gulf-to-Bay Boulevard.

The oral rabies vaccine is sealed in a covering that ruptures when the raccoon bites into the fish meal bait. It's not harmful to humans or pets, Agnew said, except that it may cause pets some stomach upset. And people with compromised immune systems should avoid the vaccine. If you find one of the baits in a high-traffic area, use a plastic bag to throw it into woods, if possible.

The bait targets raccoons, the primary source of rabies in Florida, though not the only source. The bait works on some other animals, like foxes and coyotes. Bats also may carry their own strain of rabies, but they eat insects like mosquitoes, not baits. "It's hard to put (vaccine) in a mosquito," Agnew said.

For information, call Pinellas County Animal Services at (727) 582-2600 or the Pinellas County Health Department, Environmental Health Division, at (727) 507-4336.

TO HELP

The Pinellas County Animobile offers $1 rabies vaccinations with an $8 county license. The Animobile will be at 1111 18th Ave. S, St. Petersburg, giving rabies shots from 1:30 to 3 p.m. Thursday and Friday. It will be at the Clearwater Health Department, 310 N Myrtle Ave., at the same times Tuesday and March 3, 4, 8, 10, 11 and 15. Pet owners also can get $5 rabies shots and an $8 county license at Pinellas County Animal Services, 12450 Ulmerton Road, Largo. Call (727) 582-2600.

The world's population is growing at a tremendous rate, affecting growth and development. Apart from this population growth, unintended pregnancies resulting in elective abortions continue to be a major public health issue. In over half of these unintended pregnancies, the women have used some type of contraception. Thus, there is an urgent need for a better method of contraception that is acceptable, effective and available. The contraceptive choices available to women at this time include steroid contraceptives, intrauterine devices, barrier methods, spermicides, natural family planning, male and female sterilisation, and recently available emergency contraceptives. Contraceptive vaccines (CVs) may provide viable and valuable alternatives that can fulfill most, if not all, properties of an ideal contraceptive. Since both the developed and most of the developing nations have an infrastructure for mass immunisation, the development of vaccines for contraception is an exciting proposition. The molecules that are being explored for CV development either target gamete production (gonadotropin releasing hormone, follicle-stimulating hormone and luteinising hormone), gamete function (zona pellucida [ZP] proteins and sperm antigens) or gamete outcome (human chorionic gonadotropin [hCG]). Disadvantages of CVs targeting gamete production are that they affect sex steroids and/or show only a partial effect in reducing fertility. CVs targeting gamete function are better choices. Vaccines based on ZP proteins are quite efficacious in producing contraceptive effects. However, they invariably induce oophoritis affecting sex steroids. Sperm antigens constitute the most promising and exciting targets for CVs. Several sperm-specific antigens have been delineated in several laboratories and are being actively explored for CV development. Antisperm antibody-mediated immunoinfertility provides a naturally occurring model to indicate how an antisperm vaccine will work in humans. Vaccines targeting gamete outcome primarily focus on the hCG molecule. The hCG vaccine is the first vaccine to undergo phase I and II clinical trials in humans. Both the efficacy and the lack of immunotoxicity have been reasonably well demonstrated for this vaccine. The present studies focus on increasing the immunogenicity and efficacy of this birth control vaccine.

PMID: 15748095 [PubMed - in process]

Not immunising children against TB should be criminalised -Ramsammy says at World TB Day observance By Daniel Da Costa Monday, March 28th 2005 Minister of Health Dr Leslie Ramsammy on Friday said he hoped to make the non-immunisation of children against tuberculosis (TB) a criminal act for which parents could be penalised.

Speaking at the observance of World Tuberculosis Day at the recently opened multi-million dollar New Amster-dam Hospital, Ramsammy noted that TB was a curable disease and he urged parents to ensure that their children are immunised against TB through available vaccinations. "It is inhumane and a horrible mistake not to immunise childrenâ€¦ It is not something to be ashamed of and all Guyanese must stop stigmatising people with TB."

Addressing a wide cross-section of health workers, regional officials and patients, Minister Ramsammy noted that the occasion provided an opportunity to highlight the seriousness of tuberculosis and the great challenge it posed to the public health sector. "We thought we had beaten TB a few years ago but today it has re-emerged as a major public health threat across the globe paralleling the HIV/AIDS crisis and claiming some 5,000 lives worldwide each day." However, TB can be cured through the Directly Observed Treatment Short-Course (DOTS) which ensures that the client takes the drugs. Full DOTS programmes have been established at the Georgetown Hospital and Prisons, Enmore Polyclinic, New Amsterdam Chest Clinic, Linden Chest Clinic, West Demerara Regional Hospital, Maba-ruma, Mahdia, Kato and Lethem while a programme is now being developed at the New Amsterdam Prisons. According to Ramsammy, the Ministry will this year accelerate the development of the DOTS programmes with assistance from the Canadian International Development Agency (CIDA) and the Global AIDS Programme (GAP).

The Department of Health, Region Six (East Berbice/ Corentyne) hosted the observance under the theme 'Health Workers can make a difference. Stop TB now through DOTS.' Among those speaking at the mid-morning ceremony on the institution's lawns were Dr Yakub Vaid, TB/HIV Co-ordinator of the US Centers for Disease Control/Global AIDS Pro-gramme (CDC/GAP) Guyana and Dr. Enias Baganizi of PAHO/WHO, Guyana Office.

Dr Vaid pointed out that one third of the world's population or some 1.86 billon people are currently infected with TB. "TB is the biggest curable infectious killer of young people and adults in the world today. Every second someone in the world is newly infected with tuberculosis while every year eight million people become sick with TB, 95 per cent of them from developing countries."

According to Dr Vaid, "if TB is left unchecked in the next 20 years, almost one billion people will become newly infected; 200 million will develop the disease while 35 million will die of it." More than 75 per cent of TB-related disease and death occurs among people between the ages of 15 to 54, the most economically important segment of the population. According to the co-ordinator up to 50 per cent of people with HIV or AIDS develop TB, while worldwide 14 million are co-infected with TB and HIV.

Tuberculosis he said remains a threat to the health and well-being of people around the world.

"Until TB is controlled World TB Day won't be a celebration. But it is a valuable opportunity to educate the public about the devastation TB can spread and how it can be stopped. TB is a global emergency but it can be cured and the spread of disease stopped."

Dr Baganizi noted that the impact of co-infection with TB and HIV is enormous. "Each disease speeds up the progress of the other and TB considerably shortens the survival of people with HIV/AIDS. TB kills up to half of all AIDS patients worldwide while most people infected with HIV in developing countries develop TB as the first manifestation of AIDS. The two diseases represent a deadly combination since they are more destructive together than either one alone."

Dr. Baganizi said he was confident that with the dedication and commitment from the Ministry of Health together with the contribution from the international donors, Guy-ana will be able to achieve the Millennium Development Goal for TB control. This includes detecting 70 per cent of new smear positive cases and successfully treating 85 per cent of these cases by the end of this year and by 2015; to halt and begin to reverse the incidence of TB and to halve TB prevalence and death rates. "We in PAHO commit ourselves to continuing our technical co-operation both with countries at a national level and between countries in the Region of the Americas to reach these goals in decreasing the burden of TB on people living in the Americas," he concluded.

Tuberculosis is a disease caused by bacteria called Mycobacterium Tuberculosis. It is spread through the air when people who have the disease cough, sneeze, talk, sing or spit. The TB germs go into the air and can infect people who breathe in the germs. The German physician Robert Koch discovered tubercle bacilli, belonging to a group of bacteria called Mycobacterium, which causes tuberculosis, on March 24, 1882.

http://www.stabroeknews.com/index.pl/article_local_news?id=14936813

Muslim parents in Mali jailed for refusing kids polio vaccines

http://news.yahoo.com/s/afp/20050511/hl_afp/malihealthislam/nc:1437

BAMAKO (AFP) - Eleven Muslim people presented before a Mali court as members of a fundamentalist sect have been given jail terms of between six months and three years for denying their children polio vaccinations, a judge said. Sidiki Sanogo, the justice of the peace who convicted and passed sentence on the 11 on Tuesday in the southern town of Yorosso, told AFP: "I was only applying the law, this sect was gaining ground in the region and its members lived in a secluded hamlet, their women cloistered separately apart."

The people sentenced included nine Malians and two citizens of the neighbouring sub-Saharan nation of Burkina Faso. One another person, a Malian, was acquitted because the court found he was "not opposed to the vaccination". Without specifying when all 12 were detained and charged, Sanogo said they were convicted of "resisting authority, disobedience and rebellion" after they refused to allow their children to be vaccinated, arguing that "God makes people sick and he saves them."

"These people are Muslims who practise an unclear rite and who want to live outside any aspect of modern times," a legal source who asked not to be named told AFP. Witnesses said that the trial proceedings were sometimes "rowdy" since the defendants stuck "tooth and nail" to their convictions. Those jailed included the Burkinabe leader of the group, Amadou Konate,described by witnesses as a visionary guru with a negative influence on others.

The National Institutes of Health is under fire from critics over a plan to test two anthrax vaccines on children.

The trial will test and compare the reactions in humans to the vaccine manufactured by BioPort Corp. of Lansing, Mich., and another being developed by NIH. Bob Bock, an NIH spokesman, said the trial planned for 100 children in first and second grade will not occur until the vaccines are fully tested on 350 adults and shown to be safe for them. "The results in this study," says an NIH announcement, "will help in the development of improved vaccines for anthrax." The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks.

Critics, however, are appalled.

"This vaccine is totally inappropriate for children, because the [exposure] threat is so remote," said Barbara Loe Fisher, president of the National Vaccine Information Center. "They will likely never be exposed to anthrax either through contamination by animal products or inhalation of weaponized anthrax."

"Children are involved in trials of vaccines that benefit children," she said, "but this vaccine will not do so." Fisher said based on the NIH announcement of "rare severe reactions" to BioPort's vaccine, she fears the parents of children used in the experiments will not be given proper warnings of the vaccine's potential for adverse reactions. However, Bock said adults and parents or guardians of the children will be given complete information on the two vaccines and their benefits and risks.

"I don't understand how they can do efficacy tests with children at the same time that we are discovering more and more U.S. soldiers who have been harmed by the vaccine," said Steve Robinson, executive director of the National Gulf War Resource Center for service members and veterans. "[NIH officials] want parents to want their children to be vaccinated against the anthrax terrorist attacks that have not happened."

But Bock said that if terrorist attacks occur, both children and adults would be at risk.

BioPort's vaccine, used almost exclusively on soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use.

Retired Air Force Col. John Richardson, who has independently researched the vaccine extensively, said that in 2003, there were 16,869 federal adverse reaction reports for all vaccines and of those, 1,068 were for the anthrax vaccine. The anthrax vaccine drew more than 6 percent of all vaccine complaints, said Richardson, even though anthrax vaccinations represented less than 1 percent of an estimated 100 million immunizations of all types administered that year.

For last year, he said, there were 15,488 federal adverse reaction reports for all vaccines, and 806 for anthrax, or 5.2 percent of the total. Complaints to the reporting system - which even federal officials acknowledge typically represent as few as 10 percent of all adverse reactions to vaccines - can be filed by vaccine users, doctors and medical personnel.

The vaccine, aimed at protecting soldiers against anthrax spores fired into the air in combat, has been under attack by service members and their advocates ever since the Pentagon mandated its use in 1998. Aside from the anthrax spore attacks aimed at government officials 3½ years ago, no such attacks are known to have been used during modern warfare or by any terrorists.

WASHINGTON -- Scientists hunting a vaccine to protect newborns from a severe infection not only found a promising candidate, they developed a new way to speed the search for vaccines against other hard-to-fight diseases, too.

It's a gene-searching technique that goes by the humble name "multiple genome screen." But the research, led by Chiron Corp., elicited a "wow" from the government's infectious disease chief. "It opens up a new arena" in developing vaccines against multiple strains of diseases, said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases. "This is a very, very elegant, potentially usable avenue to go after that whole concept of universal vaccines."

The first candidate: a possible vaccine against Group B strep, a germ that lurks harmlessly in many women's bodies but that can befatal or brain-damaging if passed to their infants during birth.So far, the experimental vaccine has been tested only in mice. But studies reported Thursday in the journal Science suggest it's the first candidate in two decades that might protect against all major strains of Group B strep. Chiron's lead researcher says the company is discussing with U.S. regulators how to begin human testing.

"We are very excited because we do have, now, something we believe will work." - Guido Grandi, Chiron vice president for research

"We are very excited because we do have, now, something we believe will work," said Guido Grandi, vice president for research at Chiron's vaccine division in Siena, Italy. Group B streptococcus, a cousin of the germ that causes strep throat, is found in up to 40 percent of women. It usually causes them no symptoms. But it's the most common cause of blood infection and meningitis in newborns.

In the United States, pregnant women are supposed to be tested for Group B strep during the third trimester, and carriers are given intravenous antibiotics during labor. That policy has cut infant infections by 70 percent since 1996 -- but still, Group B strep sickens about 2,500 U.S. newborns each year and kills 80 to 100. There are numerous strains of the germ, and previous attempts at vaccines couldn't offer universal protection.

Enter the new genetic technique.

Instead of laboriously growing the bacteria in laboratory dishes -- a usual step in vaccine creation -- the scientists used computers to rapidly identify all the genes in eight major strains of Group B strep. First they teased out genes shared by all the strains, said Herve Tettelin, a molecular biologist with The Institute for Genomic Research, a Rockville, Md., nonprofit group that collaborated with Chiron. Then they identified additional genes that produce proteins on the germs' surface -- easy for the immune system to spot and thus important for a vaccine, he explained.

Mouse testing revealed four proteins that seemed to spark the most immune response. So the scientists brewed those four proteins into a single vaccine, inoculated adult female mice, mated them and exposed the resulting babies to Group B strep.

The vaccine proved 87 percent protective. ( it doesn't work then)

Chiron is most interested in testing the experimental vaccine in teenagers, to see if protection would last years later when they became pregnant, Grandi said.

More exciting, the genetic-screening technique may help develop vaccines against a variety of microbes where multiple-strain protection is a roadblock, said Fauci, whose National Institutes of Health division helped fund the research. "We'll certainly be pursuing it," he said. Already, Tettelin said his research group is using the technique to identify the genes in multiple strains of food-poisoning E. coli, bacterial pneumonia and a potential bioterror agent called burkholderia.

The present invention is based on the discovery that a single immunization with a nucleic acid vaccine, delivered orally to a fetus through the amniotic fluid, induces high serum antibody titers and cell-mediated immune responses in immunized fetuses, as well as in the newborn subjects. Moreover, this route of delivery provides direct access to a number of potential mucosal sites in the upper and lower respiratory tract, induces local immunity in the oral cavity and does not induce immune tolerance. In utero nucleic acid immunization, therefore, provides an efficient means of limiting vertical transmission of infectious diseases before, during and after birth.

Global Drug Industry Launches All-Out Attack on Rights of Thimerosal-Injured Children Thimerosal is a mercury-based additive to vaccines that has potentially poisoned hundreds of thousands of American children. Faced with the prospect of thousands of lawsuits seeking compensation for the devastating injuries caused by thimerosal poisoning, the international pharmaceutical companies and their army of lobbyists are pushing a bill in Congress to wipe out the rights of children and their families to get legal relief. Rather than seek an answer in a fair court, these corporations have instructed Senator Frist to champion legislation that would refuse these children their day in court. Sponsored by Senator Bill Frist (Republican, TN), the legislation known as SB 2053 or "the Frist Bill" would:

require that every thimerosal-injury lawsuit currently pending anywhere in America be immediately dismissed

force thimerosal injury claims into a bureaucratic administrative program in Washington, DC that is not designed to handle these claims

prohibit any judge from ordering the drug companies to provide the money for desperately needed research and medical monitoring of children exposed to thimerosal forever deprive any child over the age of 8 of any legal remedy whatsoever, either in the courts or in the federal administrative program prohibit class action lawsuits related to thimerosal injuries and thimerosal exposure. This website will give you the background information and tools you need to defeat this anti-child, anti-justice, pro-industry bill. Time is of the essence, and making sure your voice as well of the voices of your friends and families need to be heard in Congress to stop this terrible bill.

Please send the following text to your Senator or the Health Committee Members listed on this page: Senator, I believe that every citizen of this country has the right to a fair pursuit of justice when wronged. The drug companies are attempting to move Frist Bill SB2053 forward quickly. It is set for a hearing in front of Sen Kennedy's Health Committee. I am asking you to refuse SB2053 (the "Frist Bill"). It is anti-child, pro-corporation and anti-justice. The Frist Bill addresses thimerosal and is specifically putting corporate welfare before that of our children. Thimerosal is a mercury-based preservative that may have damaged thousands of children. These children and their families have the right to pursue this issue in court. The Frist Bill blocks that right unilaterally and in perpetuity in all venues.

I ask you, Senator, as a protector of our nation to choose our children over the corporations in this matter and stop the Frist Bill from going forward.

washingtonpost.com Study: Experimental AIDS Vaccine Safe for Babies

By Maggie Fox Reuters Wednesday, February 12, 2003; 11:52 AM

An experimental AIDS vaccine seems to be safe for babies born to women infected with HIV, and early signs suggest it may help protect them from infection, U.S. researchers said Wednesday. The vaccine, made by Aventis Pasteur, is one of dozens being tested although few experts believe any of them could actually prevent HIV infection in a global population.

Instead, doctors are hoping to use different vaccines on different groups in the hope of preventing some infections. One of these areas is in mother-to-child transmission of the AIDS virus. About a quarter of children born to HIV-infected mothers catch the virus, either during birth or through breast milk.

Giving the mother and baby drugs can reduce this risk, but a vaccine might be safer, more effective and perhaps cheaper. A network of doctors across the United States, led by Dr. Elizabeth MacFarland of the University of Colorado Health Sciences Center, tested Aventis Pasteur's experimental ALVAC-HIV vCP205 – which is a vaccine using canarypox, a distant relative of the virus used in the smallpox vaccine – combined with several proteins from the AIDS virus.

The idea is to prime cells to recognize and destroy cells infected with HIV. They tested 23 babies with four doses of the vaccine. All were born to HIV-infected mothers in the United States. It was a phase I-II study designed to show that the vaccine was safe, not to prove it works, said Aventis Pasteur's Jim Tartaglia.

"It wasn't designed as an efficacy trial. You would have to do a whole new trial to show that," Tartaglia, head of research for the company, said in a telephone interview. The study showed the vaccine was safe, with no serious side-effects in the babies, the researchers told the 10th annual Conference on Retroviruses and Opportunistic Infections in Boston, the major annual scientific meeting on AIDS.

Tartaglia said it often takes a long time, sometimes years, to determine whether a baby has contracted the AIDS virus. The babies were not tested to see if they contracted HIV but the vaccine did cause an immune response in the babies, which would suggest it may help to prevent HIV infection.

DISCUSSIONS IN AFRICA?

Tartaglia said Aventis Pasteur is now deciding what to do next. He said the company would discuss this with authorities in Africa – the region hardest-hit by HIV – and the National Institutes of Health in the United States.

A separate team of researchers tested a slightly different version of the vaccine in HIV-infected adults who had been keeping the virus controlled using drugs. A strong cocktail of medicines known as highly active antiretroviral therapy or HAART can keep AIDS at bay and keep patients healthy, but they are expensive and have unpleasant side-effects. And the virus can eventually mutate to resist the drugs, forcing doctors to re-formulate the cocktail.

Many researchers are testing the idea of a "drug holiday" to give patients a break and the give the body a chance to fight the virus on its own. A team of French researchers told the conference they tested 48 patients on HAART with four doses of the vaccine. Four months after starting, they were taken off HAART.

Again, the study was meant to show the approach was safe and the researchers noted no severe reactions to the vaccine. After 44 weeks, 21 percent of the patients still have the virus well under control and have not needed to re-start the drugs, they said. Tartaglia stressed it is too soon to tell whether the vaccine can be used to relieve patients on HAART.

"Is it a six-month drug holiday? Is it a 12-month drug holiday? I think we are in the early stages of the field," he said. Based in Lyon, France, Aventis Pasteur is owned by French drugmaker Aventis SA. if it doesn't work, give more is their insane science........

Government vaccine advisers have recommended every child between six months and four years receive a booster vaccination against Haemophilus influenza type b. The Joint Committee on Vaccination and Immunisation is concerned the effect of the Hib vaccine, given to children at two, three and four months, wears off over time.

Full Text: Copyright CMP Information Ltd. Jan 27, 2003

Hib vaccine

By Rob Gough

Government vaccine advisers have recommended every child between six months and four years receive a booster vaccination against Haemophilus influenza type b. The Joint Committee on Vaccination and Immunisation is concerned the effect of the Hib vaccine, given to children at two, three and four months, wears off over time.

Latest figures from the Public Health Laboratory Service show rates of Hib infection in the under-fives have increased four-fold from 0.68 per 100,000 in 1998 to 2.81 in 2001. The joint commitee has advised the Department of Health to begin a one-off catch-up vaccination programme, immunising all children currently between six months and four years old with an extra dose of the vaccine.

Committee members said at their last meeting that although the UK programme had been highly successful, 'further enhancement of immunity appears necessary'. Dr Mary Ramsay, consultant in public health at the Public Health Laboratory Service's immunisation division, said many cases of Hib were occurring in children whose immunity had declined after getting the vaccine. 'We really need to do this now,' she warned.'Everybody under four years old is at increased risk.'

Dr Ramsay said it was not yet known whether a routine booster would have to be added to the vaccination schedule. 'The campaign, if it goes ahead, would be a temporary holding measure. Once that's happened we'll be able to see whether we need a booster in the long- term,' she added.

GPC joint-deputy chair Dr Hamish Meldrum said GPs would be paid for giving the extra Hib dose as an additional service under the new contract. 'We're still discussing ways additional services will be funded,' he said. 'It will almost certainly not be funded by an item- of-service fee.' A department spokesman said it was still 'considering options' for the vaccination campaign.

GIARDINI NAXOS, SICILY, Italy, April 11 (UPI) -- The first vaccine designed to protect children simultaneously against measles, mumps, rubella and chicken pox appears promising in preliminary studies, researchers reported Friday. The vaccine, being developed by Merck Research Laboratories of West Point, Pa., is exciting doctors because they see the potential of increasing vaccine coverage for infections of varicella, the organism that causes chicken pox.

"This is first in the world vaccine aimed at these four major childhood diseases," said Dr. Jay Lieberman, a researcher at the UCLA Center for Vaccine Research in Torrance, Calif. "We think that if we can reduce the number of shots young children have to take to be protected against these diseases we have the potential to get our numbers up to around 90 percent vaccinated against chicken pox," he told United Press International. Lieberman presented his findings at the annual meeting of the European Society for Pediatric Infectious Diseases.

Vaccination for varicella -- recommended for U.S. children under age 2 --has a wide range of coverage state-to-state. About 70 percent of the U.S. childhood population is covered. "The drive in this field is to combine vaccines," said Dr. Jodie McVernon of the Public Health Laboratory Service Communicable Disease Surveillance Center in London. "The more visits you make to the doctors, the worse your vaccine coverage is likely to be." In his presentation, Lieberman, who also is associate professor of medicine at the University of California, Irvine, said his study compared the ability of vaccinated children to produce antibodies to the diseases in three different lots of the medication -- a step required by the U.S. Food and Drug Administration to show the vaccine can be manufactured consistently.

The vaccine was administered to about three-quarters of 3,928 healthy children ages 12-to-23 months. The other children were given one injection of the MMR-II (measles, mumps, rubella) vaccine, which has been given to children for decades. These children also received a second injection of Varivax -- a chicken pox vaccine. The shots generally were given in each arm. Researchers looked at seroconversion -- how well antibodies to the diseases developed -- after the inoculations were performed. They found the results were similar for each vaccine lot and, in turn, were similar to seroconversion seen in children receiving the two approved vaccines. Lieberman also reported:

--In measles, 97.6 percent of children receiving experimental ProQuad vaccine showed seroconversion, compared to 98.5 percent of those getting the two vaccines.

Lieberman said children receiving ProQuad appeared to suffer more fevers in the six weeks following the inoculations -- 39.1 percent vs. 33.1 percent -- but he said he did not think the figures were clinically relevant. However, he noted there was no difference between the group receiving ProQuad and those getting the two vaccines, in terms of developing worrisome, fever-related seizures. Lieberman said he expects Merck likely will file with the FDA for approval of the vaccine "soon" but he said he was not aware of an exact timetable to do so.

"Doctors are excited about the idea that they can deliver this vaccine in one shot," Lieberman said. "That has the potential to enhance compliance especially against chicken pox at an early age."

http://abcnews.go.com/wire/US/reuters20030416_779.html

April 16 — By Ransdell Pierson

NEW YORK (Reuters) - U.S. scientists have asked more than a dozen American and European healthcare companies to help develop a vaccine to protect against SARS, the flu-like disease that has killed 159 people around the globe. But officials from companies who attended the meeting in Washington last week said it could take years to come up with a safe and effective vaccine.

Top scientists from the U.S. Centers for Disease Control and the National Institutes of Health last week issued the call for help, at a meeting attended by Secretary Tommy Thompson, head of the U.S. Department of Health and Human Services. "Now that the virus has been identified, the government made it clear it wants to talk to anyone who can make a vaccine," said Una Ryan, chief executive of Avant Immunotherpeutics, a small company that is developing an oral vaccine to protect against both anthrax and plague infections.

Company officials said the government scientists gave updates about SARS, but have not yet offered specific financial assistance to get their research rolling. Ryan said government scientists at the meeting favored the quickest possible vaccine approach -- of growing the virus, killing it and then delivering it by injection to spur protective antibodies against future infection with the virus. "Developing a vaccine from a killed virus is the quickest and easiest thing to do," Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases, said in an interview.

"You grow the virus, kill it, and there you go. You have a vaccine. But it would still take years to actually have the vaccine in the bottle and ready to distribute," Fauci said, because of the need to prove its safety and effectiveness. U.S. and Canadian scientists earlier this week said they had independently mapped the genome of the coronavirus blamed for SARS. It has been carried to a score of countries in the past six weeks, killing about 4 percent of those infected. Attendees at the meeting included U.S. vaccine makers Merck & Co. Inc., Wyeth, Chiron Corp., Vical Inc. and Avant, as well as Europe's GlaxoSmithKline Plc, Aventis, PowderJect Pharmaceuticals Plc and Berna Biotech .

Also on hand for the meeting were U.S. healthcare companies Johnson & Johnson and Baxter International Inc. . Fauci said companies could also help by testing whether their drugs work against SARS, including ones "sitting on their shelves" that have never been approved. "Another more-sophisticated route would be for companies to design drugs that interfere with structural and regulatory genes of the virus," Fauci said. Such an approach was used to develop pills that control HIV, the virus that causes AIDS.

Scientists have not yet developed an effective vaccine against HIV. Researchers have shied away from developing a vaccine using a killed virus because HIV, unlike SARS, is life-threatening to almost everyone it infects, Fauci said. "With HIV, we have been concerned that if you inject someone with the 'killed' virus and you have not actually killed it, you might inadvertently infect the person." Scientists agreed it could take years to analyze the SARS virus and develop a vaccine. "This is a tough target. You have to grow the virus in a cell line, kill it, test it, and you need a highly secure facility in which to do all this," said Vijay Samant, the chief executive of Vical. Vical is working with the government to develop vaccines against anthrax, ebola and malaria.

"The meeting in Washington last week was only an information-sharing session, so we're still trying to determine what role to play," said Merck spokeswoman Janet Skidmore. Skidmore noted Merck has been working for a decade to develop an HIV vaccine, and said it could take awhile for an effective SARS vaccine to emerge. Ryan said Avant favors developing an oral vaccine, loading key proteins called antigens from the surface of the SARS virus into live but genetically disabled cholera bacteria. He said this could be more effective and safer than the approach the government favors. "We will be dependent on the government to identify which antigens from the virus they think should be used," Ryan said. Aventis, the world's biggest vaccine maker, has already given government researchers a culture made of monkey kidney cells in which to grow and test the virus that causes SARS. "We don't know what next step we can take to help, but we're ready to partner with the government in whatever manner that makes sense," said Aventis spokesman Len Lavenda.

Lavenda said Aventis has several highly secure laboratories for performing studies with dangerous bacteria and viruses, all of which are now being used. "But perhaps one or more of them could be converted for SARS research." (Additional reporting by Toni Clarke)

http://www.ama-assn.org/sci-pubs/amnews/pick_03/hlsc0526.htm

HEALTH & SCIENCE

Scientists eye new developments on the vaccine front The vast range of pathogens and their ability to mutate beyond the reach of many antibiotics continue to challenge researchers.

By Susan J. Landers, AMNews staff. May 26, 2003.

Washington -- Vaccines that target influenza, measles, polio and pneumonia are wiping out those infections that have long taken a toll on human life. But there are plenty of other pathogens to keep microbe hunters on the job developing new vaccines to eradicate infections that are fatal to many patients, especially the youngest, oldest and most frail. Microbiologists, epidemiologists and public health physicians gathered early this month for updates on the ongoing search for new vaccines at the 6th Annual Conference on Vaccine Research in Arlington, Va. The conference was sponsored by the National Foundation for Infectious Diseases.

Presentations ranged from the search for a safer, next-generation smallpox vaccine to those that prevent infection by such nasty bugs as Staphylococcus aureus and Clostridium difficile. The threat of bioterrorist attack has kept the smallpox virus center stage, prompting researchers to step up work on a new vaccine that can be used safely to inoculate individuals not currently deemed eligible for the existing one.

For instance, individuals who have a compromised immune system or a history of eczema are cautioned against receiving the smallpox vaccine unless there is an actual smallpox outbreak.A new smallpox vaccine is being evaluated, said Richard N. Greenberg, MD, professor of medicine at the University of Kentucky College of Medicine in Lexington, although, because of the small numbers of volunteers in the trial, there is no definitive outcome.

Resistant Staphylococcus aureus appeared in 2002.

"The new vaccine, known as CCSV, contains a strain of the vaccinia virus that is grown in cell culture," Dr. Greenberg said. DryVax, the vaccine now in use to immunize those deemed first responders to bioterrorist attacks, contains a similar virus but was produced by infecting cows. Vaccines that target the following infectious agents also were described as being in varying stages of development, although none has gained Food and Drug Administration approval for general use.

Staphylococcus aureus. A phase III clinical trial has shown that the vaccine StaphVAX is providing some immunity against S. aureus infections among a group of trial participants who were undergoing hemodialysis. The new vaccine targets a sugar molecule on S. aureus that allows the pathogen to evade the body's immune system. Findings from the trial were published last year in the New England Journal of Medicine.

Another vaccine, Veronate, has completed a phase I trial.

Providing urgency to the development of an effective vaccine is the increase in antibiotic-resistant strains of S. aureus and their emergence as a source of community-acquired infection. This constantly growing resistance to existing antimicrobials is troubling. The bacteria have been resistant to penicillin since the 1940s, and strains resistant to methicillin have been noted since the 1960s. Resistance to vancomycin, the so-called last resort antibiotic, surfaced in 2002.

By 15, almost all children with cystic fibrosis harbor Pseudomonas aeruginosa.

Pseudomonas. A vaccine to target Pseudomonas aeruginosa has been sought for years. It would be particularly important for children with cystic fibrosis. By 15, nearly 100% of children with the chronic disease harbor large numbers of the bacteria that cause pulmonary infections. Phase I trials have now concluded for the vaccine candidate Cytovaxine. Respiratory syncytial virus. In the United States, it is estimated that 70,000 to 126,000 infants are hospitalized annually with RSV pneumonia or bronchiolitis. RSV can also cause life-threatening pulmonary disease in bone marrow transplant recipients, and it is a major source of infection for elderly people. Two types of candidate vaccines are in clinical trials.

Clostridium difficile. Vaccines are also in development for C. difficile, a major cause of diarrhea among hospitalized elderly and immunocompromised patients. The pathogen is also responsible for most cases of antibiotic-related diarrhea.

http://news.bmn.com/news/story?day=030430&story=1

BCG gets new lease of life against HIV 29 April 2003 12:00 GMTby Julie Clayton

BCG, the vaccine that has lost favor in many countries for its poor level of long-term protection against tuberculosis (TB), could have a new lease of life as a vehicle for an HIV vaccine, say researchers. The strategy could ultimately prove more affordable and practical for developing countries, they say, compared with DNA-based vaccines currently in clinical trials. "DNA vaccines are so expensive to make they're really not suitable in the real term," said Enid Shephard, immunologist at the University of Cape Town's Department of Medicine, and principle investigator at the South Africa AIDS Vaccine Initiative (SAAVI). In her view, cost effectiveness is going to be a major criterion when deciding whether or not a particular vaccine is likely to become widely available.

In South Africa, BCG vaccination is routinely given to all children as part of a national childhood vaccination program. Despite its poor level of protection specifically against TB, the vaccine is widely acknowledged to help protect more broadly against a number of different infections, including helminth parasites (worms), by triggering Th1-type immune responses, which favor antibody production and the release of inflammatory cytokine mediators, says Shephard.

"Children actually fight off other infections if they are BCG-positive," she said, adding that they also appear to be less prone to certain allergies. The BCG program also means that the necessary infrastructure is already in place for delivering a BCG-based HIV vaccine.

So far, in tests on mice, a recombinant BCG construct containing a selection of HIV genes appears to be equally as effective for boosting responses as is a DNA-based vaccine. In both cases, mice were first exposed to an initial DNA-based vaccination. The next steps will be to see if the recombinant BCG vaccine can work alone in triggering HIV-specific responses, and to test its efficacy in baboons, according to Shephard.

"Recombinant BCG as a vector has some advantages," agreed Pontiano Kaleebu, virologist and principle investigator for the International AIDS Vaccine Initiative (IAVI) vaccine trial at the Uganda Virus Research Institute in Entebbe. "It is not expensive, the vector has been extensively administered in humans worldwide, and it's safe."

Kaleebu cautions, however, that no one yet knows the effect that prior BCG vaccination may have in individuals receiving a recombinant BCG-based HIV vaccine. "These have to be evaluated."

In the meantime, SAAVI's DNA-based vaccine is already further down the pipeline, and may enter Phase I safety trials in around 18 months time, depending on animal toxicity studies, according to Shephard's colleague Anna-Liese Williamson of the Department of Clinical Laboratory Sciences and Institute of Infectious Disease and Molecular Medicine at the University of Cape Town.

"To have vaccines made in such a short time is more than we thought we would achieve," said Williamson, "I'm a believer that we should have as many trials as possible so that we can get information to figure out what works."

SAAVI is a consortium of labs and hospitals forming Africa's first home-produced pipeline for taking experimental HIV vaccines from the bench to the clinic. In particular, their vaccines focus on the sub-type C clade of HIV, which prevails in South Africa. The DNA-based vaccine will be tested in a prime-boost strategy similar to that already in clinical trials elsewhere, including the University of Oxford's candidate now in Phase II trials in Oxford, London and Nairobi, and the IAVI Phase II trial in Uganda.

The SAAVI DNA vaccine contains a combination of HIV antigens (gag, reverse transcriptase, Tat and nef) and is being produced to good manufacturing practice standards by UK firm Cobra Therapeutics. This will be used for an initial vaccination, or primer, to be followed by a second booster step with another vaccine based on the smallpox-like vector, modified vaccinia Ankara (MVA). The latter is in production at the US-based company Therion.

The DNA vaccine has so far been tested in both mice and baboons. "Our DNA results are very promising," said Shephard, who presented unpublished data at this week's Federation of African Immunological Societies meeting in Victorial Falls, Zimbabwe.

Malaria kills millions of African children yearly. For many decades malaria vaccines have been sought but have been dismal failures. NATURE and BBC report that a vaccine experiment will be conducted in 2,000 children in Mozambique--even though the vaccine's safety has only been tested in adults in small phase I trials.

The sponsors are GlaxoSmithKline and the Malaria Vaccine Initiative (MVI, funded by the Gates Foundation). In addition to the malaria parasite protein, the vaccine contains "a fragment of hepatitis B" and an adjuvant. Nature reports that the vaccine trial sponsors (GSK and MVI) claim that in the adult tests the vaccine (RTS,S) "protected up to 71% of adults from being infected with malaria."

However in the next paragraph the article notes that Melinda Moree,director of the MVI admits that "Chances of success are slim. We're going to hear more about failures than successes....Even negative results move us quite a way forward,' she says." BBC reports that in the adult trial the vaccine’s protective action wore off after two months. The experiment raises serious ethical concerns that need to be addressed before 2,000 children are exposed to an experimental vaccine that the sponsor admits is likely to fail:

1. What are the subjects' parents told about the vaccine?

2. Since the vaccine has not been tested in children before, its safety in children has not been assured. Therefore this is essentially a phase I safety trial. Why then, are 2,000 children being exposed before its safety in children has been established?

3. If the efficacy rate in the small phase I adult trials was 71% what led the sponsor to state that the vaccine's "chances of success are slim"?

4. What were the negative findings of the adult trials?

5. What is the adjuvant used with the vaccine? 6. What is the adjuvant's toxicity in humans--since it is not licensed in the US?

7. What is the toxicity of the portion of the Hepatitis B virus that is included, given that France halted its countrywide Hepatitis B vaccination program several years ago due to serious neurologic side effects in a minority of recipients?

8. Since the vaccines protective effect of the vaccine in the adult safety trials wore off after just two months, does the sponsor and those conducting the trial anticipate inoculating the children every two months?

9. If so, what evidence is there that multiple shots are safe? Shouldn't children’s exposure to an experimental vaccine be guided by precautionary measures? Phase I (vaccine safety trials) do not test multiple inoculations.

10. What is the ethical justification for a “trigger happy cowboy approach?” Should scientists be allowed to take risky leaps without adequate safety data and expose 2,000 children to an experimental vaccine that the sponsor admits has “slim” chances for success?

The most advanced test of a vaccine against malaria ever conducted in children begins in Mozambique next week. The hope is that immunization will become a primary weapon in the fight against malaria, which kills 1 million Africans each year, most of them toddlers and babies. Currently, drugs - to which resistance is rapidly developing - and protections like bed nets are the only ways to control the disease.

Two thousand children under five will take part in the trial, funded by the Malaria Vaccine Initiative (MVI), an independent organization based in Rockville, Maryland, which coordinates international efforts to develop malaria vaccines, and drug giant GlaxoSmithKline. "This is the largest malaria vaccine trial carried out in Africa to date," says Pedro Alonso, scientific director of the study's base, the Manhiça Health Research Centre in Mozambique.

Tests with small numbers of volunteers have satisfied researchers that the candidate vaccine - called RTS,S - is safe. The next stage, a phase 2 trial, will now ask whether the vaccine actually prevents malaria in children. Results should be available in 18 months.

RTS,S consists of a protein found on the surface of the malaria parasite at the stage when a mosquito's bite injects it into the human body. It also contains a fragment of the hepatitis B virus, too little to cause the disease, but large enough to goad the body's immune system into recognizing the malaria fragment.

A chemical mix called an adjuvant is the final ingredient. This tricks the immune system into mounting a strong immune response to the vaccine, helping it to remember the crucial parasite protein. In tests in the Gambia, RTS,S protected up to 71% of adults from being infected with malaria. If the vaccine has similar success in children it must then pass further tests in babies. Those under a year old are excluded from this trial for safety reasons but are at the highest risk of dying from malaria.

Chances of success are slim, admits Melinda Moree, director of the MVI. Only one of 80 current malaria vaccine concepts is estimated to succeed, she explains: "We're going to hear more about failures than successes." But a clinical trial is the only way to find out what approaches do and don't work. "Even negative results move us quite a way forward," she says.

That RTS,S is in the most advanced stages of testing doesn't mean it is the best candidate vaccine. It has been in development since the 1980s and has the backing of a large company, says Adrian Hill at the University of Oxford, UK. Hill's team is working on a different approach using modified viruses to carry malaria genes into the body; initial results are promising1. Around nine other candidate vaccines are also in safety trials this year.

Twins stop breathing after jabs Calls are being made for more information about the safety of vaccinations for premature babies after twin brothers nearly died. Niles and Harvey Johnson, who were born nine weeks prematurely, stopped breathing within hours of having their first vaccinations.

Their father, Tom, resuscitated them while his wife, Melanie, telephoned for an ambulance. Although Niles and Harvey survived, their parents say they were not warned of the risks vaccines posed for premature babies. Daventry and South Northamptonshire Primary Care Trust said the benefits of vaccines outweighed the risks, but it would be investigating the case.

The twins had their first injections at a GP surgery near their home in Long Buckby on 21 August just over a week after arriving home. The first vaccinations are to immunise babies against whooping cough, diphtheria, tetanus, meningitis and polio. We just went into a state of panic - you just don't expect to see your babies stop breathing

Melanie Johnson Mr and Mrs Johnson said hours later their eight-week-old babies were rushed to hospital with breathing difficulties. "We just went into a state of panic. You just don't expect to see your babies stop breathing," said Mrs Johnson. "Thank goodness Tom was able to stimulate them while I was on the phone to the ambulance. "We thought all the problems were all behind us - we thought when we came home we would be a happy family." She added: "It could have been a very different Saturday morning we were waking up to."

Mr and Mrs Johnson want more information given to parents of premature babies warning of the possible dangers of injections. Daventry and South Northants Primary Care Trust said such side-effects were very rare. The trust has arranged for the twins to have their next injections in hospital, where they will spend 48 hours under observation.

Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/northamptonshire/3198721.stm

Published: 2003/09/01 17:57:05 GMT

"Niger: Focus on the Vaccination of Nomadic Children" Africa News Service (www.allafrica.com) (10/08/03)

UNICEF says that few of Niger's children have been vaccinated against preventable diseases; Niger has nomadic tribes, who are hard to track. According to UNICEF, almost 30 percent of Niger's children die before they are five--in large part due to preventable diseases--so the organization has decided to focus on preventative actions, protection issues, and development. During August, the national vaccination rate of children up to 11 months old climbed to 50 percent, but UNICEF says that some southern districts are resisting the polio vaccination due to religious or cultural beliefs. UNICEF makes use of an annual ceremony held by the nomadic tribes, vaccinating children at the celebrations.

Potentially revolutionizing the pharmaceutical industry, researchers are developing an implantable microchip capable of delivering precise doses of several different drugs over a period of months. The chip is likely to benefit patients taking numerous drugs per day as well as doctors who want to ensure the complete dosage is taken by the patient. The chip could also release multiple doses of a vaccine, which could ensure patients are fully immunized even if they live in rural areas and are unable to reach clinics for multiple doses of a vaccine. Current time-release technology in capsules or patches release the drugs continuously, but the chip is able to release specific dosages at specific intervals. Cost is an issue keeping the technology from reaching the general public. Once the chip has completed its tasks, it degrades within the body and is gone within a matter of months. The technology is currently undergoing clinical trials in order to receive Food and Drug Administration approval.

Nabi Biopharmaceuticals has developed a vaccine against the Staphylococcus aureus bacterium. The vaccine, called StaphVAX, is important because antibiotics currently used to treat staph infections could eventually become ineffective as the bacteria develop resistance to the drugs. StaphVAX is currently undergoing clinical trials with dialysis patients; however, it could eventually become useful for any hospitalized patient at risk of infection. The vaccine could prove useful to as many as 12 million Americans per year, according to market-research firm Mattson Jack Group. Nabi hopes to enter the European market with StaphVAX in two years and the U.S. market by the end of 2006.

Can't you just hear the CHA CHING?

http://www.healthypages.net/newspage.asp?newsid=3842

Chickenpox vaccine okay for nursing mothers 2003-11-18 16:32:13

NEW YORK (Reuters Health) - The virus that is used in the chickenpox vaccine doesn't seem to enter a mother's breast milk or pass to feeding infants, new research shows. This means that nursing mothers who are susceptible to chickenpox do not need to wait to get the vaccine. Although chickenpox is often thought of as a childhood illness, adults can get it too and usually it is much more serious than in kids.

Because chickenpox can be especially harmful during pregnancy, the vaccine is recommended for susceptible, non-pregnant women of childbearing age. Ideally, vaccination would occur before pregnancy, but, in reality, many susceptible women are not identified until after they've given birth.

Based on reports of certain viruses being excreted in breast milk, there has been concern about giving the chickenpox vaccine to breastfeeding mothers. However, it was not known whether the vaccine virus did find its way into breast milk or even if exposing babies to the virus was harmful. To investigate, Dr. Kari Bohlke, from Group Health Cooperative in Seattle, and colleagues tested for the virus in blood and milk samples obtained from 12 women who received two doses of the vaccine while breastfeeding. In addition, blood samples were obtained from the mothers' infants and tested for the virus.

As reported in the medical journal Obstetrics and Gynecology, none of the 217 milk samples obtained after vaccination showed any evidence of the virus. Moreover, there were no signs of the virus in blood samples taken from the babies. "Although we cannot completely exclude the possibility that excretion (into breast milk) occurs, these findings suggest that vaccination should not be delayed in breast-feeding women who are known to be (chickenpox) susceptible," the researchers note.

"Offering the first vaccine dose before a susceptible woman is discharged after delivery and the second dose at the postpartum follow-up visit would provide early protection for the woman and would facilitate compliance with the two-dose vaccine schedule," they add.

SOURCE: Obstetrics and Gynecology, November 2003.

http://www.newscientist.com/news/news.jsp?id=ns99994318

US develops lethal new viruses

19:00 29 October 03

A scientist funded by the US government has deliberately created an extremely deadly form of mousepox, a relative of the smallpox virus, through genetic engineering. The new virus kills all mice even if they have been given antiviral drugs as well as a vaccine that would normally protect them. The work has not stopped there. The cowpox virus, which infects a range of animals including humans, has been genetically altered in a similar way.

The new virus, which is about to be tested on animals, should be lethal only to mice, Mark Buller of the University of St Louis told New Scientist. He says his work is necessary to explore what bioterrorists might do. But the research brings closer the prospect of pox viruses that cause only mild infections in humans being turned into diseases lethal even to people who have been vaccinated.

And vaccines are currently our main defence against smallpox and its relatives, such as the monkeypox that reached the US this year. Some researchers think the latest research is risky and unnecessary. "I have great concern about doing this in a pox virus that can cross species," said Ian Ramshaw of the Australian National University in Canberra on being told of Buller's work. Ramshaw was a member of the team that accidentally discovered how to make mousepox more deadly (New Scientist, 13 January 2001). But the modified mousepox his team created was not as deadly as Buller's. No rebound

Since then, Ramshaw told New Scientist, his team has also created more deadly forms of mousepox, and has used the same method to engineer a more deadly rabbitpox virus. But this research revealed that the modified pox viruses are not contagious, he says. That is good news in the sense that these viruses could not cause ecological havoc by wiping out mouse or rabbit populations around the world if they escaped from a lab.

However, this discovery also means some bioterrorists might be more tempted to use the same trick to modify a pox virus that infects humans. Such a disease, like anthrax, would infect only those directly exposed to it. It would not spread around the world and rebound on the attackers. But there is no guarantee that other pox viruses modified in a similar way would also be non-contagious. Ramshaw's team made its initial discovery while developing contraceptive vaccines for sterilising mice and rabbits without killing them. The researchers modified the mousepox virus by adding a gene for a natural immunosuppressant called IL-4, expecting this would boost antibody production.

Instead, the modified mousepox virus was far more lethal, killing 60 per cent of vaccinated mice. The addition of IL-4 seems to switch off a key part of the immune system called the cell-mediated response.

Maximised production

Now Buller has engineered a mousepox strain that kills 100 per cent of vaccinated mice, even when they were also treated with the antiviral drug cidofovir. A monoclonal antibody that mops up IL-4 did save some, however. His team "optimised" the virus by placing the IL-4 gene in a different part of the viral genome and adding a promoter sequence to maximise production of the IL-4 protein, he told a biosecurity conference in Geneva last week. Buller has also constructed a cowpox virus containing the mouse IL-4 gene, which is about to be tested on mice at the US Army Medical Research Institute of Infectious Diseases at Fort Detrick, Maryland.

Cowpox infects people, but Buller says the IL-4 protein is species-specific and would not affect the human immune system. The experiments are being done at the second-highest level of biological containment.

Nine-eleven

Ramshaw says there is no reason to do the cowpox experiments, as his group's work on rabbits has already shown the method works for other pox viruses. While viruses containing mouse IL-4 should not be lethal to humans, recombinant viruses can have unexpected effects, he says. "You'd hope the combination remains mouse-specific."

Why his group's engineered viruses are not contagious is a mystery, he says. It is not, for instance, because the host dies faster than usual, taking the virus with it. But his findings could explain why pox viruses containing IL-4 have never evolved naturally, even though the viruses frequently pick up genes that affect their host's immunity. Despite the concerns, work on lethal new pox viruses seems likely to continue in the US. When members of the audience in Geneva questioned the need for such experiments, an American voice in the back boomed out: "Nine-eleven". There were murmurs of agreement.

Debora MacKenzie, Geneva

CPS finally swoops in, just not in right case

Oct. 15, 2003 12:00 AM

When the call came in this summer about a 7-year-old boy living in a closet, Child Protective Services was too busy to check it out. A few days later, police found the boy, stripped and starving. When the call came in about 3-year-old twins in cages, CPS declared it a low priority and tossed it to a social worker who couldn´t get past the front door. This summer, police found the boys, now 5, still living in filthy cages.

When the call came in about a mother who decided her kids did not need rabies shots, well, you can imagine what happened. That´s right. CPS was on her in an instant. Within hours of getting a complaint, no less than a unit supervisor showed up on Anita Masse´s doorstep in Strawberry, threatening to immediately seize her three children. This, because Masse wouldn´t agree to get the painful shots to guard against a disease she felt they had no chance of contracting.

Neighbors were shocked to hear that CPS was knocking on the Masses´ door. "This is an exemplary family here," said Dee Cox, who lives across from the Masses, on Peach Lane. "Every kid should be so lucky to live in a home like this. It´s the last home in Arizona where you would expect CPS to come."

Apparently, no longer. Comes now the inevitable other end of the spectrum of child protection, the ultimate result that you knew would come when CPS began taking heat for all the times it didn´t do enough to protect children. Comes now the next swing of the CPS pendulum: overreaction in all the wrong cases. The Masses live in a trim home tucked into the woods of Strawberry, just a ride through the pines up from Payson. Dominic works in construction while Anita takes care of the kids: Rebecca, 11, Cody, 10, and Emily, 8.

Their problems began in July when bats got into the house. At first, it was one or two at a time, sightings that would send the parents running for a broom and a dustpan and the kids running for cover. Dominic tore out the ridge of the roof to find out how the bats were getting in and fix it. Unfortunately, he didn´t build in an escape route for the bats already in the rafters. The family was watching TV the evening of July 27, when six bats suddenly swept into the living room.

The Masses stayed at the Coxes that night and the next, after five more bats were found. Meanwhile, Anita called Gila County Rabies Control for help. She got it - and more.

County workers told her that state health guidelines say you should get rabies shots if you´ve been bitten, scratched or slept in a room with a bat that has not been tested. But Anita says none of those things happened with her children. After doing some research - talking to her pediatrician, state biologists and the local hospital - Anita decided the shots weren´t necessary. Meanwhile, two of the bats were tested and came up clean. Still, the county continued to insist, so Masse called a reporter and appeared on TV, suggesting that if the state wanted her to get shots, the state should pay for them. Within 24 hours, Mary Meyers, a CPS supervisor, was at her door with an ultimatum: agree to the shots or lose your kids tonight.

In the eyes of CPS - eyes that see no immediate danger in parents who closet or cage their kids - Masse was providing an unsafe home. So unsafe, according to CPS records, as to require that the children be immediately taken and parceled out into foster care. Of course, Masse couldn´t let that happen so she agreed to force her children to endure the painful shots. Shots which, by the way, are recommended by the state, not mandated.

CPS wouldn´t discuss the case, employing the usual confidentiality dodge. Craig Levy, the bat expert at DHS, acknowledged that the recommendations are advisory only. "You´d hope that parents would make the appropriate decision to protect their kids," he added. But the thing is, Anita Masse thought she had made the appropriate decision. She knows the disease is fatal. She also contends her kids were never near the bats. "I go out of my way to protect my children," she said. "If I had ever thought they were in danger they would have gotten the shots. It´s not up to the state. I think that it is my decision as a parent."

Apparently not. Not anymore.

http://nachrichten.boerse.de/anzeige.php3?id=775c11cf

Developing and Launching Novel Medicines and Vaccines

In addition to the 2003 submissions, Merck has novel vaccine candidates and a diabetes drug in its late-stage pipeline. The company expects to submit a Product License Application (PLA) to the FDA for its PROQUAD vaccine, a pediatric combination vaccine for measles, mumps, rubella and chicken pox, in the second quarter of 2004. Merck expects to file PLAs with the FDA for three novel vaccine candidates in the second half of 2005: a human papillomavirus (HPV) vaccine; a shingles (zoster) vaccine; and ROTATEQ, a vaccine for rotavirus-induced infant diarrhea.

Merck's investigational HPV vaccine has the potential to be the first vaccine to prevent HPV infection and is expected to have the broadest HPV coverage in vaccines currently known to be in development. HPV infection can lead to the development of cervical cancer, which is the second-most common cancer in women. Cervical cancer impacts approximately 470,000 women each year and leads to more than 200,000 deaths. An estimated 30 million adolescents and adult females in the United States are at risk for developing HPV infection. Enrollment in Merck's large Phase III quadrivalent HPV vaccine program is complete, with approximately 17,000 subjects enrolled. The HPV vaccine is expected to reduce the risk of HPV infection and the associated development of cervical cancer and genital warts. HPV 16 is one of the more serious forms of HPV and is associated with cervical cancer deaths. Merck's Phase II proof-of-concept study with an HPV 16 vaccine showed 100-percent efficacy. The company is confident that competing intellectual property claims will not delay the HPV program. Enrollment in Merck's large Phase III program for a zoster vaccine is complete. The vaccine is being developed for the prevention of shingles, a painful condition, which affects up to 1 million adults each year in the United States and is caused by the reactivation of the chicken pox virus.

Each year, rotavirus-induced infant diarrhea leads to more than 500,000 physician visits and 50,000 hospitalizations in the United States and causes more than 400,000 infant deaths in the developing world. Currently, no rotavirus vaccines or anti-viral treatments exist for the prevention of rotavirus. Merck's Phase III trial for ROTATEQ is under way with more than 60,000 infants enrolled.

The company is also studying a DP-IV inhibitor, a glucose-lowering mechanism used alone and in combination for the treatment of Type II diabetes. The number of people suffering from Type II or Non-Insulin Dependent Diabetes Mellitus today in major pharmaceutical markets is 40 million and that total is expected to more than double to 90 million by 2015. Merck plans to enter Phase III with this investigational compound in the second quarter of 2004 and expects to submit an NDA to the FDA in 2006.

In addition to reviewing the late stage pipeline, Peter S. Kim, Ph.D., president of Merck Research Laboratories, outlined the company's preclinical and Phase I and II programs during the meeting. Merck's research programs, which span 28 therapeutic categories, focus on the development of novel medicines that can address large, unmet medical needs.

"When you look at the Merck pipeline, from preclinical to Phase III," Dr. Kim said, "you can see the breadth and depth of our work in the areas of diabetes, obesity, Alzheimer's disease, respiratory disease, coronary heart disease, rheumatoid arthritis and vaccines. We are pleased with the developments in our early stage pipeline and with the new technologies that give us the potential to move compound candidates into later stages for development faster than before. For example, we expect to move our DP-IV candidate from preclinical to Phase III in just over two years, compared with the industry average of just over four years."

A group of 30 British families who blame a controversial pesticide for causing their babies to be born without eyes have won a historic breakthrough in their quest to get justice and multi-million pound compensation. Ten years after The Observer first revealed the possible link between the agricultural chemical Benlate and this tragic medical condition, the Supreme Court in Florida has ruled that the fungicide was responsible for causing the birth defects.

After fierce legal wrangles and appeals through the US courts, judges have awarded an American family almost $7 million (£3.9m) in damages after their son was born with empty eye sockets in 1990. The US chemical giant DuPont, which made Benlate and has spent millions of dollars fighting the case, is understood to have already handed over the money to the family.

It is the first time in legal history that a chemical company has been found guilty of causing birth defects. The case has echoes of Thalidomide, the drug found to cause babies to be born with deformed limbs. The American judges concluded that John Castillo's condition was caused as a result of the boy's mother, Donna, being sprayed with Benlate when she was seven weeks pregnant in November 1989 as she walked past a fruit farm in Florida. Benlate was used for years on farms and in gardens in Britain to control fungal infections until DuPont took it off the market two years ago.

Jim Ferraro, the American lawyer who acted for the Castillos and is representing the British families, said: 'This is a major victory and we now hope to win justice for the British families who have suffered for years from this tragedy.' Next year the affected British families are to sue DuPont in Delaware, the home state of the chemical giant. Marty Griffin from Norfolk, whose son Darren was born with only one eye in 1995 and who is suing DuPont, welcomed the development.

'This is fantastic news,' he said. 'It shows that a large corporation cannot railroad over the terrible problems its chemicals have caused. My wife was exposed to Benlate very early on in her pregnancy and we are absolutely convinced that it caused Darren's problems. 'When he was born, the hospital in King's Lynn had never seen anything like it before and there is no family history of any eye defects. We are looking forward to our day in court, when we hope to finally get justice for Darren.'

The safety of benomyl, the chemical ingredient of Benlate, has been questioned for several years. In 1991 scientists at the University of California discovered that more than 40 per cent of pregnant rats fed high levels of benomyl produced foetuses with severe eye defects. When the dosage of benomyl was administered to rats given a protein-deficient diet, almost two out of three pregnant animals gave birth to babies without eyes. The study was designed to show the impact of the chemical on those with a poor diet.

As long ago as 1972, the US official watchdog, the Environmental Protection Agency, advised that DuPont should put a label on Benlate warning that it could 'cause birth defects ... and exposure during pregnancy should be avoided'. But lobbying from DuPont persuaded the EPA that the warning was misleading and unnecessary, so it never appeared.

One of the most dramatic pieces of evidence to emerge during the legal disputes has been an internal DuPont report on research the company funded in 1997 by an independent laboratory in Yorkshire. Scientists tested benomyl on rats and discovered that a 'high' proportion of the chemical was drawn to the eyes. The report revealed that after two hours a third of the benomyl was concentrated in the eyes, rising to two-thirds after 24 hours. After 10 days, 80 per cent of the benomyl was pooled around the eyes.

Some scientists believe this reveals how the eyes act as a kind of powerful magnet to attract the benomyl and explains how the chemical destroys the eyes of a foetus. DuPont has always argued that humans could be exposed to large doses of this fungicide without any risks to health. But scientists say the risks are at a very different level for a foetus at the very early stages of pregnancy, when the essential structures of a baby's eye and brain are being formed. DuPont has recently withdrawn Benlate from the global market because of mounting litigation costs.

The company has always denied that Benlate was the cause for the birth defects and argued that the families' claim was based on 'junk science'. It claims to have spent more than $1.3 billion over the past decade fighting Benlate lawsuits and paying damages. Most cases have emanated from hundreds of growers of flowers, ornamental plants and food crops who alleged that the fungicide wrecked their produce.

antony.barnett@observer.co.uk

Better than a McDonalds voucher I suppose.

Susan

No link available.

Cairns Post, The (Australia) November 6, 2003

ANY Cairns child aged between four and seven who is immunised in the next three months will go in the draw to win a bike. The promotion, by the Cairns Division of General Practice, aims to address an alarming shortfall in the number of children who receive their scheduled four-year-old immunisations. GP's spokeswoman Wendy Wall said children at that age should be vaccinated against several diseases including diphtheria, tetanus, whooping cough, mumps, measles, rubella, meningococcal C and polio. "Immunisation is so important and parents should ensure their children are fully immunised," Dr Wall said.

The bike has been donated by Cairns Bicycle Works.

http://www.medilexicon.com/medicalnews.php?newsid=5149

TB bacteria may have key to preventing diabetes 04 Jan 2004

Scientists in Australia are investigating whether the bacteria responsible for tuberculosis (TB) could prevent childhood diabetes. Childhood diabetes, also known as insulin-dependent and type one diabetes, occurs when the body's immune system attacks its own insulin-producing cells in the pancreas.

James Cook University Comparative Genomics Centre head Alan Baxter has disclosed his research suggests a link between diabetes and the lack of exposure to bacterial infections. 'If the immune system is busy fighting other infections it tends not to cause the tissue damage associated with diseases like diabetes,' he said. 'It's like a teenager at the movies - if it's a good movie they stay occupied but if it's not, they get bored and start cutting up the seats.'

Experiments exposing diabetes-prone mice to Mycobacterium bovis, the cattle TB found in unpasteurised milk, found they did not develop the disease. Dr Baxter said his Townsville-based Australian research unit had isolated a molecule of the bacteria which could be administered without causing other diseases.

A phase one trial on humans by the Centenary Institute in Sydney is scheduled for mid-2004, although a second trial will be needed before scientists can describe it as a breakthrough.

'We've taken the bacteria used for the TB vaccine, grown enormous amounts, crushed them and then isolated one molecule,' Dr Baxter said. 'It's that molecule we will be administering. 'Instead of using live bacteria, we're injecting a small amount of killed bacteria ... by not using live bacteria, even if someone has got HIV they won't get infected.' Dr Baxter said his theory linking diabetes and lack of exposure to bacteria is supported by a rise in type 1 diabetes after World War II.

Since then pasteurized milk and sanitized lifestyles, involving a proliferation of bacteria-fighting cleaning agents, have become the norm. 'The incidence of type one diabetes has doubled every 15 years since the Second World War,' Dr Baxter said. 'Back when people had TB in World War II there was a very low incidence of type one diabetes. 'It's our hypothesis that type one diabetes is related to lack of exposure to bacterial infections, but it's not proven yet ... in the mice, we've certainly proven it.'

January 21, 2004

White House Seeks to Control What Public Learns About Health, Environmental Emergencies ****This is the first of two articles on this subject. The second will appear tomorrow.****

How and what Americans are told about public health emergencies would be controlled by the White House, not by the agencies with the medical or scientific expertise to handle these crises, under a new plan proposed by the Office of Management and Budget (OMB).

The proposal would strip authority from federal health, safety and environmental agencies and give the White House final say over how the public is told about such emergencies as nuclear power plant accidents, outbreaks of mad cow disease or drugs that are found to be harmful.

Critics fear such a move would delay the release of critical public information and politicize the way it is presented. In comments submitted to the OMB, Dr. Jordan Cohen, president of the Association of American Medical Colleges, and Robert Wells, president of the Federation of American Societies for Experimental Biology, described several recent public health emergencies where delays in releasing information could have endangered the public. Among those examples were the emergency termination of a clinical drug trial that showed the drug was dangerous, and the announcement that hormone-replacement therapy was more harmful than beneficial to many post-menopausal women. [1]

OMB's "Proposed Bulletin on Peer Review and Information Quality," which could take effect as early as several months from now, is also being opposed by a group of former top federal agency officials from both Democratic and Republican Administrations. [2]

White House Seeking Control Over Scientific Peer Review of Environmental, Health Research Which Shapes Federal Policies ****This is the second of two articles on this subject. The first appeared yesterday.****

Environmental and health studies conducted for or used by the federal government would require White House approval before their release, under a proposal now under review at the Office of Management and Budget (OMB). The plan would also give the White House authority to select which scientists take part in the system known as peer review -- the process by which fellow researchers evaluate the validity and reliability of studies before they are published.

Critics fear such a plan would undermine the impartiality of research that guides government policies and regulations. For example, it would open the door for the Administration to hand-select industry-friendly scientists to review studies that investigate the safety of chemicals in our food and consumer products, or studies that examine the environmental impact of energy plant emissions. The White House has frequently expressed its commitment to easing regulations for American industries. [1]

In a January 9 letter to the OMB, 20 former top federal agency officials, from both Democratic and Republican administrations, urged the White House to drop its proposal. The letter -- signed by former EPA Administrators Carol Browner and Russell Train; former Secretary of Labor Robert Reich; former Assistant Secretaries for Occupational Safety and Health Eula Bingham and Gerard Scannell; and others -- warned that the proposal, "in its current form, could damage the federal system for protecting public health and the environment." [2]

Currently, each federal agency controls peer review of its own projects. The government's rules to ensure research quality are already less stringent than those used by leading biomedical journals. For example, these journals require authors to disclose who paid for the research; and the journals will only publish studies done under contracts in which the investigators have the right to publish regardless of the results. Federal agencies do not have these requirements, nor do they consistently attempt to find out who paid for the studies. [3]

Far from ensuring the validity of the peer review process, the plan's critics assert that allowing the White House to control it would only add a layer of politics to what should be a purely scientific process. [4]

NEW YORK (Reuters Health) - US researchers have used a protein found in Listeria monocytogenes, a microbe that can cause food poisoning, to create more effective vaccines. The protein, known as listeriolysin O (LLO), helps the bug break through the walls that surround the body's cells. Given this effect, the researchers believed that the protein might also help vaccines gain entry into cells, resulting in a stronger immune response. "We harnessed the clever invasive machinery of Listeria and developed it into a potentially safer and more effective vaccine delivery formulation," senior author Dr. Kyung-Dall Lee, from the University of Michigan in Ann Arbor, said in a statement.

"We've shown that vaccines produced using the listeriolysin O protein can dramatically boost the immune response" in mice, he added. In the current study, Lee's team injected mice with an LLO vaccine against a test virus, a regular vaccine against the same virus, or an LLO vaccine against no virus. After being vaccinated, the animals were then injected with the virus to see if the vaccine protected them from infection. The new findings are reported in the journal Molecular Pharmaceutics.

Mice given the LLO vaccine against the test virus showed a stronger immune response than did animals that received the other vaccines. Moreover, treatment with this vaccine completely protected the animals from death after virus injection, whereas the other vaccines did not. "We're very excited about this promising vaccine delivery system, which could pave the way for the next generation of safer, more effective vaccines," noted Lee, who holds a patent related to the LLO delivery method.

SOURCE: Molecular Pharmaceutics, January 2004.

From: http://new.globalfreepress.com/article.pl?sid=03/12/30/1827249

Illegal Aerial-Aerosol ‘Vaccines’ Coming…

Michael Kane continues with his series about the latest BioDrills and possible connections with Bio-Weather Modification Weapons

Judith Miller broke the story of a secret cabinet level experiment named “Scarlet Cloud”, in the NY Times on Dec. 28th. Miller writes that officials stated the exercise “…showed that antibiotics in some cities could not be distributed and administered quickly enough and that a widespread attack could kill thousands” – she referred to anthrax.

So what is the solution? Judith doesn’t go into this in her piece, but if you read her epic book “Germs” and pay close attention, you clearly see what the “solution” is in the minds of DARPA.

Aerial-Aerosol Vaccination

“Perhaps someday the military would have a detergent that could be sprayed over people and neutralize an anthrax attack” (J. Miller: “Germs”, pg. 307). DARPA – the Defense Advanced Research Project Agency, gave Maxygen a $3.8 million contract in 1998, and a $7.7 million contract in 1999. (Maxygen reports the contract as $6.7 million)

Maxygen says this is a three year grant to use it’s proprietary MolecularBreeding ™ directed evolution technology to protect against a broad spectrum of Pathogens. Maxygen is involved in what they themselves call “gene-shuffling”.

The military asked Maxygen to develop aerosol-based vaccines that could be inhaled to safeguard people against a broad range of pathogens. Shaun Jones, the first director of DARPA’s Unconventional Countermeasures program has said the value of many of their programs will not be known till they are tested on people (J. Miller: “Germs”, pg 308)

On May 11th, 2000, Clifford Carnicom posted the findings of strange red blood cells in a ground sample believed to be part of an aerosol operation. Could this have been part of the testing Jones contends is necessary for one of DARPA’s projects? That is unknown, and what makes it a harder nut to crack is that the EPA has refused to test the sample in question (which was sent to Carol M. Browner, former head of the EPA).

411 blackout – testing ground for aerosol “vaccinations”?

I myself witnessed an aerial-aerosol spray operation at 8pm on August 14th, 2003 during the east coast blackout. I believe, just like 911, the 411 blackout was a war game. Part of that war game scenario involved aerosol spray operations, but what for?

I am convinced the spin for this, when the government is forced to fess-up to portions of what really happened during the 411 blackout, will be that they were running “drills” for mass aerosol vaccination of the public. Of course, the claim will be that they did not spray “live” vaccine, but rather they were testing the effectiveness of the delivery method via placebo. Who knows what the rank of the lie will be; but they will be forced to recognize what they were doing, and why, at some point, and this is the spin they will use.

Is it true?

Possibly, but to get a more accurate picture of truth we must delve deeper into this. Many top doctors and medical experts feel most vaccines have never been proven to prevent disease, quite to the contrary. Many vaccines directly weaken the immune system, and often times, can cause the disease they are meant to “vaccinate” you from.

Might there be a hidden agenda behind “vaccines”? The leading research on the dangers surrounding vaccines has been compiled by Gary Null. Well worth reading - vaccines are not what they seem. Here is one of the best summaries I’ve ever heard about vaccines, in laymen terms, from Verney-Elliot…

“The vaccine scam works like this. Identify and magnify an ‘epidemic’ disease, whip up world panic, and devise a vaccine against the supposed causative agent. Administer the vaccine, preferably just before the epidemic starts to wane naturally, and then, when the cases of the disease start to diminish, claim the vaccine has worked and the pharmaceutical company who manufacturers it will get the credit for saving mankind. There will be bouquets and Nobel prizes all round and every one makes a lot of money. One has only to look at the cases of the anti-polio and anti-smallpox vaccine campaigns to see the classic modus operandi in taking credit for ending the epidemics, which in the manner of all self-limiting phenomena, were already dying out before the vaccine was introduced…

Are vaccines scams? The answer is usually: Yes, at least a scam, often worse.

Forcing Illegal Vaccines on Soldiers

The military was ordered by the courts to stop using it’s soldiers as guinea pigs for experimental, likely dangerous, anthrax vaccines. But back in October, the government gave an $80.3 million contract to Vax Gen Inc. to develop yet another experimental anthrax vaccine. That is a serious contract. Obviously there must be those in the military-industrial complex who are not pleased with that court decision.

www.anthraxadeadlyshotinthedark.com. Even President Clinton (not one of my favorite people) banned experimental vaccines on military personnel with a Presidential Executive Order, in September of 1999. It seems every few years they bring back mandatory military anthrax experimentation.

Oops! Did I say “experimentation”? - I meant to say “vaccination”

Maxygen & AIDS

In September of 2000, Maxygen announced a collaboration with the Scripps Research Institute to identify potential vaccine candidates for an HIV vaccine.

In February of 2001 Maxygen announced collaboration with the IAVI – International Aids Vaccine Initiative, and DBLV, LLC, an entity established and funded by the Rockefeller foundation, to work on an AIDS vaccine. http://www.maxygen.com/newsview.php?listid=112

“Vaccines” in the Air?

Can we really trust the military to vaccinate our air? These are the same people who put Gulf War I veterans through hell from depleted uranium - and guess what else? You guessed it, anthrax vaccines.

Of course we can’t trust them to “vaccinate” our air! One only need reference “Clouds of Secrecy”, written by Leonard A. Cole, which documents clandestine American military aerosol operations unleashed in the subways of New York and sprayed in San Francisco. Cole details the case of Edward J. Nevin, who died of a mysterious infection in a Standford hospital. His grandson filed suit in 1981 against the government, claiming the aerosol operation in San Francisco was responsible for his Grandfather’s death. The judge in the case barred a scientist from testifying on the plaintiff’s behalf (J. Miller: “Germs”, 347 note 42). The entire escapade reeked of cover-up.

Then there is Project Shad, which Judith Miller leaves out of her book “Germs”. The book is 400+ pages and I have not read all of it, but Project Shad is not listed in the book’s extensive index. Let us not forget, this is the same Judith Miller who used Ahmed Chalabi as an unidentified source for her spectacular (and now completely discredited) weapons of mass destruction claims before Gulf War II in Iraq.

Project Shad was the despicable U.S.G. experimentation - spraying aerosol clouds over tugboats filled with Americans. VX Nerve agent and Sarin gas were used, but the military never said exactly when this was done. To admit the exact date of such an illegal experiment leaves those who were responsible wide open for prosecution. Guardian

More, more, more

DARPA, the government agency supporting many of Maxygen’s experimental vaccination programs (from our tax dollars), has seen budget increases from $59 million in 1998 to $162 million in 2001, and estimated to rise to $205 million by 2005 (Miller, Germs; pg 308). DARPA has also brought us Total Information Awareness (TIA) – the big brother system created by convicted criminal John Poindexter designed to rape any-&-all concept of privacy rights.

Keep your eyes on the sky and your ear to the ground peace eternal

Michael Kane was organizer of the 9/11 Investigative Film Exhibition and Panel in New York at Riverside Church, September 2003. He is staff member of SGTV and GFP since 2003.

In early 2004, his group Kane + Salem will release a 9/11 album which will also cover other dark secrets of the U.S. Government.

http://www.vidyya.com/vol6/v6i25_4.htm

New vaccine for herpes in final trial phase

Approximately one in four women in the United States has genital herpes. Symptoms are often subtle, and most people don't know they have herpes, but genital herpes is among the most common infectious diseases. This is why Mount Sinai School of Medicine has joined with the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline Biologicals in the Herpevac Trial for Women. Healthy women aged 18-30 may be eligible to participate in the trial.

The herpes virus causes cold sores and genital herpes. Although thousands or millions of Americans have the disease, 90% are unaware of this infection. Even people who do not have visible symptoms can spread the disease. The disease burden is estimated at between $300 million to $1 billion per year in the US alone. There is no treatment that can eliminate the virus.

The Herpevac Trial for Women is investigating a promising vaccine to protect women against genital herpes. This vaccine does not contain live virus and cannot cause herpes infection. It has passed preliminary testing for safety and effectiveness and is now in its final phase of clinical trials.

For this study, Mount Sinai and the more than 20 other sites involved in the trail are seeking to enroll approximately 7,550 women. The Herpevac Trial for Women is open to healthy females between the ages of 18 and 30 who are negative for both HSV-1 and HSV-2.

Women who are interested in volunteering for the clinical trial will receive a very accurate blood test that looks for antibodies (the immune system's response) to both HSV-1 and HSV-2. Participants can obtain results of the test by calling the Herpevac Trial for Women Test Result Hotline two weeks after having the blood drawn. In addition to providing results, this Hotline has trained counselors to answer questions about the test and test results so that women who test positive for herpes can understand what this means to them.

Volunteers will be randomly assigned to receive either the candidate herpes vaccine or and an investigational hepatitis A vaccine. Participants will receive three doses of either vaccine within the first six months of the trial and will be followed for a total of 20 months through periodic clinic visits and contacts.

a Centre for International Health, Burnet Institute, Melbourne, Australia b Nelson Mandela School of Medicine, University of Natal, Durban, South Africa c Department of Immunization, Vaccines and Biologicals, Initiative for Vaccine Research, World Health Organization, 1211, Geneva 27, Switzerland

Received 9 July 2003; revised 15 December 2003; accepted 7 January 2004. ; Available online 28 January 2004.

Abstract

The first generation of HIV vaccines will soon be here, but many questions remain unanswered regarding their administration. For instance, which vaccines should be given to whom at what age and how many doses? We argue that pre- and early-adolescents will be one of the main target groups for future HIV vaccines, that is, before the age of exposure to the virus. Historically, immunization has mainly focused on infants. Indeed, vaccines have only occasionally been systematically targeted at adolescents, even in industrialized countries. Delivering vaccines to pre-adolescents and adolescents in developing countries would, to a great extent, be a new challenge.But it is not just HIV/AIDS vaccines that are coming down the pipeline. Herpes simplex type2 (HSV-2) and human papillomavirus (HPV) vaccines are also among the exciting candidate vaccines that may be the agents of change needed to encourage even the poorest countries to develop strategies for reaching adolescents with vaccines and other health services in the coming decade. Together, they may also provide the impetus for changing the paradigm for how vaccines are administered.Not only will more antigens be included in national immunization schedules, but the age of target groups will range much more widely than at present, encompassing older children, adolescents and young adults. While presenting major difficulties for delivery, these new ingredients also offer stimulating opportunities to completely rethink how vaccines are presented, administered and delivered. We predict that even the poorest countries will be looking to developing integrated, sustainable strategies for reaching pre-adolescents and adolescents with vaccines in the coming decade. Author Keywords: Immunization; HIV/AIDS; Vaccines

a York Health Economics Consortium Ltd., Level 2, Market Square, University of York, York YO10 5NH, UK b National Centre for Immunisation Research and Surveillance, University of Sydney, Sydney, Australia

Received 2 July 2003; accepted 24 November 2003. ; Available online 29 January 2004.

Abstract

Hospitalisation and death from pertussis in highly immunised populations largely occurs before the first vaccination at 2 months. A Markov model was constructed to estimate the costs and health consequences of three strategies to reduce pertussis over the first 6 months of an infant's life. Earlier vaccination (at either birth or 1 month in addition to current practice) or vaccination of the parents soon after birth was compared with the current practice of vaccination at 2, 4 and 6 months. The model was populated using data on the incidence and costs from Australia. Disability-adjusted life-years (DALYs) were used as the primary outcome measure. The cost to the Australian public health system was chosen as the economic perspective, and Monte-Carlo simulations were used to accommodate uncertainties in the variables.Vaccination at birth was estimated to cost (S.D.) an additional A$33.21 (A$1.60) per infant and to reduce cases, deaths and DALYs by 45%. Vaccination at 1 month was estimated to cost an additional A$43.24 (A$8.98) per infant and to reduce morbidity by approximately 25%. Parental vaccination at birth was the most expensive alternative, costing an additional A$73.38 (A$4.98) per infant and reducing pertussis morbidity by 38%. The costs per DALY averted were A$330,175 (A$15,461) A$735,994 (A$147,679) and A$787,504 (A$48,075) for the birth, 1 month and parental vaccination strategies, respectively.Changing the estimated factor by which hospitalisations and deaths are under-reported, and the efficacy of early vaccination, had large effects on results. Parental vaccination at birth was most cost-effective where protection persisted for subsequent children. The birth vaccination strategy appears to offer the greatest potential benefit for one-child families, but the efficacy at birth (and 1 month) needs to be established. Author Keywords: Economic evaluation; Costs; Whooping cough; DALY; Health outcomes Corresponding author. Tel.: +44-1904-433-620; fax: +44-1904-433-628.

A new vaccine that targets the cause of tonsillitis could protect against one of the biggest causes of heart disease in Aboriginal people, Queensland scientists said today. The vaccine, being developed by the Queensland Institute of Medical Research (QIMR), is designed to target Group A streptococcus (GAS), a bacteria which causes tonsillitis and can lead to rheumatic fever and rheumatic heart disease. "(This) is a unique vaccine because it uses small protein fragments rather than a weakened form of the bacteria itself, which conventional vaccines against infectious diseases currently use," said Dr Colleen Olive.

"This new technology uses (those fragments) combined with lipid (fat) components, ... which help target the vaccine to the immune system to stimulate a strong protective response." The vaccine is also designed to target parts of many different types of GAS, Dr Olive said, so it should remain effective even if the bacteria evolves. "A small part of the protein has been identified that is virtually identical amongst all GAS strains," she said.

"This ... was used to immunise mice and shown to generate protective antibodies against multiple GAS strains." GAS usually makes itself known as tonsillitis, but repeated infections lead to the more serious rheumatic complications. Australia's Aboriginal population has the world's highest rate of rheumatic heart disease, which causes irreversible damage to heart tissues and valves, leads to heart failure and shortens life expectancy to an average of just 33 years.

Current treatment for GAS infection is with antibiotics - when the infection turns into rheumatic fever the patient must take high-dose antibiotics for the rest of their life.

Today’s children get a series of shots to prevent diphtheria, tetanus, measles, mumps, hepatitis B and a host of other maladies. Making sure children get these required shots just got easier for parents in the Seguin Independent School District. The district formed a partnership with the Texas Department of Health allowing school nurses to become trained and licensed to give immunizations at school.

Texas Department of Health spokesperson Maria Jimenez said the state is providing the vaccines, syringes, alcohol, bandages, paperwork and information sheets, as well as emergency kits to have on hand in case of allergic reactions to the shots. Parents are notified of immunization opportunities and must return signed permission sheets and fees to their child’s school. The first SISD immunization clinic in Seguin was held last month at Joe F. Saegert Middle School, where about 100 Saegert students received immunizations. A clinic at A.J. Briesemeister Middle School Monday provided immunizations to about 50 students. “This is a win-win situation,” said Yolanda Guerrero, registered nurse, with SISD Health Services.

"It helps the parents, because they don’t have to take time off from work to take their children in to be immunized. It helps the school because the students don’t have to spend so much time out of class to get their shots,” Guerrero said. Middle School students and freshmen typically need Hepatitis B and tetanus immunizations, said Carolyn Whitener, licensed vocational nurse, who works at the freshman center.

Students at the Seguin High School Freshman Center can get immunized Tuesday. Whitener completed the training and said the nurses hope to coordinate with the elementary schools next year to give immunizations to the 4-year-olds during registration. Guerrero and Whitener said they became interested in providing the service at Seguin schools when they heard at a conference that other schools were providing immunizations for students and staff. It took more than six months to get the training and complete all the requirements to provide immunizations at school. “We’ve crammed as many [school immunization] clinics as possible into May,” Guerrero said. “Next year, we’re ready to go.” Guerrero said parents still need to take children in for well-child checkups with their regular doctor, even if they get their immunizations at school.

http://www.wtok.com/home/headlines/790942.html WTOK-TV May 25, 2004

Healthwatch: Birth Control Vaccine? Sciencentral Karen Lurie

Researchers are working on an annual shot that would use a woman's immune system to prevent unwanted pregnancy. Stephanie McEvoy does yoga to calm herself after a day spent parenting her teenage son. "I feel like raising children is like being pecked to death by a chicken," joked McEvoy.

This frustration, along with other reasons, made her decide not to have more children, so McEvoy uses a birth control patch, but she has to remember to change it on the same day every week. "You're not supposed to forget to change the patch," McEvoy said. Now, Peter Sutovsky, a reproductive biologist, is creating a more convenient form of birth control that works like a flu shot. As reported in Discover Magazine, the shot blocks fertilization using the immune system, not hormones. So far, he's used it in a lab with eggs and sperm from pigs. "It does not affect hormonal levels, for instance, which I believe is very important especially with regard to possible side effects of altering hormonal levels in the body," said Sutovsky of the University of Missouri.

Normally, a sperm fertilizes an egg after bursting a cap on its head, releasing molecules that eat a hole through the egg's protective coating. Then, one sperm pushes inside through the hole. Sutovsky envisions an injection that would trigger the body's immune system to disable those sperm molecules so they can't break into the egg.

"Maybe a good analogy would be if you drop a little drop of acid on a wooden table. If the acid is neutralized it wouldn't do any damage," said Sutovsky. Nevertheless, McEvoy said she has her doubts. "Sometimes when you get a flu shot you get flu symptoms. If there were even a remote chance that I would be nauseas for a year I wouldn't take that medicine," said McEvoy. The shot doesn't disturb hormonal levels, so Sutovsky says he believes there won't be side effects, but years of research are ahead. Meanwhile, McEvoy continues to put up with the patch.

Researchers at the Vaccine and Gene Therapy Institute (VGTI) and the Oregon National Primate Research Center at Oregon Health & Science University have received a $3.5 million grant from the National Institutes of Health to develop new methods for vaccinating humans against human immunodeficiency virus (HIV), the virus that causes AIDS. Louis Picker, M.D., associate director of the VGTI and director of the institute's vaccine program, will serve as principal investigator of the five-year study. The National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, is funding this research. The research team is hoping to develop a new class of viral vaccine vectors to serve as the basis of HIV vaccine. Vectors are modified viruses used to safely deliver proteins from a disease-causing virus to the body. Vectors infect individuals, but do not cause any disease themselves. Rather, they serve to present the proteins from a disease-causing virus to the vaccinated person's immune system. This presentation allows the system to generate an immune response capable of protecting the vaccinated person from subsequent encounters with the disease-causing virus.

Most of the HIV vaccine development to date has focused on weakened viral vectors designed to infect the vaccinated person only briefly, insuring that the vector itself does not persist and potentially cause problems. For example, current approaches for HIV vaccines include weakened versions of the smallpox vaccine virus (vaccinia) or adenovirus engineered to produce HIV proteins. Both of these vectors can only survive for a limited time in the human body before they are eliminated by the immune system. While these vectors can generate high anti-HIV immune responses immediately following vaccination, these responses decline with time and may not produce an immune response of the correct characteristics to contain a chronic aggressive virus like HIV.

"Unlike other infectious diseases successfully countered by vaccines, HIV is very robust and able to evade most immune responses," explained Picker. "One theory about why the AIDS vaccines developed so far have not been entirely effective is because they provide only a brief period of time for the anti-HIV immune response to develop, perhaps compromising the protective capacity of the response as well as its ability to persist over subsequent years. We believe a persistent viral vector could produce a superior and more durable anti-HIV immune response that would, in effect, hold the line against HIV."

The OHSU researchers are hoping to develop a viral vector based on cytomegalovirus (CMV). It's believed that approximately 70 percent to 90 percent of the population currently is infected with CMV, a virus that causes little to no effects in immunologically normal hosts, but generates large immune responses that persist for life. CMV vectors have the capacity to re-infect such already infected individuals and generate immune responses to new proteins engineered into the vector. To develop and test this vaccine method, scientists will study animals at OHSU's Oregon National Primate Research Center.

"What makes CMV such an attractive viral vector is a combination of its strong ability to stimulate immune responses and its limited effect on the host," explained Jay Nelson, Ph.D., director of the VGTI and a co-investigator of the study. "More importantly, CMV infections last a lifetime. Therefore, we believe that HIV proteins delivered through a modified CMV vector may boost and maintain anti-HIV immunity enough to protect a person against AIDS throughout his or her lifetime."

In addition to constructing and testing candidate vector based on CMV, the scientists will measure its effectiveness. Investigators will also test vaccine delivery methods and further explore the reasons behind previous AIDS vaccine failures. http://www.ohsu.edu/

Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.

Tetanus remains a leading cause of maternal and neonatal morbidity and mortality in developing countries. It is caused by the release of two toxins produced by Clostridium tetani, a noninvasive gram-positive anaerobic bacillus. Tetanospasmin is taken up by the neuronal end plates and prevents neurotransmitter release at the synaptic junction. This leads to spasms and is irreversible. Recovery requires the formation of new neurons and may take months. Generalized muscle spasm, respiratory compromise, and autonomic dysfunction are all common clinical manifestations. Diagnosis is based mainly on history and clinical examination. The management of the pregnant woman is similar to the nonpregnant individual. The main objectives are prompt prevention of further toxin absorption, wound debridement, antibiotic therapy, and aggressive supportive care. Primary and secondary prevention protocols are important worldwide because tetanus is a preventable disease. The tetanus toxoid vaccine can be given in pregnancy. (Pregnancy? Can you imagine?)

Some members of the Apostle Church of God in Botswana are facing jail sentences and fines for refusing to allow their children to be vaccinated against polio in the country's latest round of immunizations, which will take place this week. The campaign will target about 200,000 children under five years in response to a new case of polio that was discovered in the northern Ngami District last month. The Apostle Church of God believes that diseases can only be healed by prayer, and its members reject any type of modern medicine. However, Botswana law enforcement and health officials have been authorized by the High Court to compel parents to have their children immunized or face fines and up to three months in jail. The government says the actions are necessary to ensure all children are immunized in the interest of public health. Police have already arrested several parents and guardians belonging to the Apostle Church of God for refusing vaccinations.

VOLUNTEER OPPORTUNITY

Your help is needed!

Panhandle Health District is recruiting over 500 volunteers to participate as "mock patients" during a Public Health Emergency Drill at the Sandpoint High School on June 19, 2004.

The Health District and its community partners are hosting the event in an effort to enhance the regions ability to prepare and respond to public health emergencies. The drill will test the Health District's ability to mobilize and operate a mass smallpox vaccination clinic in the event of a bioterrorism attack in our area.

This effort cannot succeed without the support of our community volunteers. We would like to invite your organization to participate in this public health preparedness event. Everyone is welcome, so feel free to invite your friends and relatives to participate in the exercise. The volunteer time commitment is approximately 1 1/2 hours. To thank you for participating, all volunteers are invited to stay and enjoy a free picnic lunch.

Again, the success of the drill depends on the support of our community volunteers. If you are interested in volunteering, please fill out the sign-up sheet (see attached) and return to: Sara Fladeland, Public Health Preparedness, Panhandle Health District, 2195 Ironwood Court, Coeur d'Alene, Idaho 83814 Tel: 208-676-1751 Fax: 208-664-8582 Sfladland@phd1.state.id.us

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The link below gives the number of smallpox vaccine doses that were shipped on 4/30/04 to all the states. While Idaho only has 1,000 doses and Arizona has 500 doses, the two Bush states seem to have plenty. Florida was shipped 24,000 doses and Texas... 30,000 doses!

http://www.cdc.gov/od/oc/media/smallpox.htm

The following link will take you to the numbers of civilians and healthcare workers by state who have been successfully vaccinated with the smallpox vaccine.

http://www.cdc.gov/od/oc/media/spvaccin.htm

And this link will take you to the number of adverse reactions that were actually reported to the CDC. These numbers appear to be incredibly low. But then again, it does not include the military where they were given smallpox with anthrax and several other vaccines all at the same time --within an hour.

http://www.cdc.gov/od/oc/media/spadverse.htm

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Activistic response -

* Organize a group to attend these meetings in your area. Make sure your group is educated on smallpox and can pepper the public health folks with appropriate questions. We suggest you spend sometime on our Smallpox Index and re-read the Smallpox Alert! http://www.vaclib.org/basic/smallpoxindex.htm http://www.vaclib.org/news/smallpoxalert.htm Have a person on the outside put our 1/2 page smallpox flyer on car windshields (at above link). Write letters to the editor, and get on talk radio, always raising issues and questions regarding the appropriateness of preparing for mass vaccination, and the planned violation of our basic right to control what we will or will not inject into our bodies.

* We have received many requests to reprint Smallpox Alert! If there are enough people who are committed to purchasing 100 - 500 copies of Smallpox Alert!, we will consider reprinting an expanded version in 24 pages - similar to the new Artificially Sweetened Times - an expose of the current epidemic poisoning America. If you are interested in reviving this publication to share among those who "simply don't know" and use this as an educational tool in your community, please contact us at the contact points in my signature.

Thanks in advance for your willingness to share accurate and vital smallpox vaccine and smallpox disease information widely. "When the majority of mankind start walking, on their own, to the slaughter house out of ignorance or apathy, it is cause for extreme alarm!" ~Onnie Kahlenberg in an email to VacLib

Hmm...maybe they are finding out how vaccines really work? They attack cells instead of prevent disease? http://www.ledger-enquirer.com/mld/ledgerenquirer/news/nation/9064918.htm Ledger-Enquirer

Posted on Fri, Jul. 02, 2004

Texan first in U.S. to try pancreatic cancer vaccine

BY JAN JARVIS Knight Ridder Newspapers

ARLINGTON, Texas - (KRT) - Every two weeks, Benjamin Butts' upper arm is injected with a clear liquid that he hopes will gobble up the pancreatic cancer inside him like a Pacman with a voracious appetite. Butts, who had his first injection June 17 at the Arlington Cancer Center, knows the odds are against him. But the vaccine, which uses a smallpox relative to attack advanced tumors, is his best chance of getting more time. "I know what I got, and I know the trouble I'm in," said Butts, 58. "There are few survivors of pancreatic cancer, but I'm looking for more time."

Butts is the first patient in the United States to participate in the Phase III clinical trial of PANVAC-VF for the treatment of metastatic pancreatic cancer in patients who have not responded to treatment with the drug gemcitabine, according to Therion Biologics Corp., the maker of the vaccine. About 50 treatment centers and 250 patients nationwide will participate in the study. It will compare the overall survival rates of those who receive the vaccine with the rates of those who receive palliative chemotherapy and the best supportive care.

Pancreatic cancer is one of the deadliest forms of cancer. The American Cancer Society estimates that 31,860 cases will be diagnosed this year in the United States and that 31,270 people will die from the disease. Only about 24 percent of people with the disease live more than a year after diagnosis. The vaccine stimulates the immune system to target and destroy two proteins found in more than 90 percent of pancreatic tumor cells, according to Therion. A virus related to smallpox helps deliver the vaccine that finds and attacks cancer cells, said Dr. Alfred DiStefano, an oncologist at the Arlington Cancer Center. "Once the virus gets into the cells, it replicates and makes a lot of viruses," he said.

Because the cancer cells can quickly become immune to the vaccine, three boosters made with a fowlpox virus relative are also given. PANVAC-VF is not a vaccine in the traditional sense of a measles or mumps shot, DiStefano said. It does not prevent cancer but was designed to recognize and destroy a foreign substance in the body, he said. For Butts and others with metastatic pancreatic cancer, the vaccine is the newest weapon for treating a disease that generally responds poorly to other therapies. Surgery to remove the cancer is difficult. Among patients who have the surgery, the five-year survival rate is about 20 percent. Radiation alone has little effect. Recent studies have found that the drug gemcitabine is more effective than other drugs in treating metastatic cancer.

The disease is especially difficult to treat because the symptoms - including jaundice, heartburn and fatigue - are not specific to the disease, DiStefano said. Butts had no obvious symptoms in July when, during a medical exam, he learned that he had the disease. "I found out I had gallstones, kidney stones and cancer all on the same day," he said. Although he had lost 50 pounds, Butts attributed it to a diet and exercise regime he had just started. He was in the best shape of his life except for the cancer, Butts said. Doctors tried to remove the tumor, but, as is often the case, the cancer had already spread. But chemotherapy and radiation reduced the tumor by 60 percent, Butts said. "They caught it soon enough for me to get treatment," he said. "Another two or three months, and I don't think they could have done anything." The treatment allowed Butts, who owns a manufacturing business in Arlington, to go on with his life. He continued working and playing golf in his free time.

In February, he learned that the cancer had spread to his lungs. He tried chemotherapy again, but the tumor was unresponsive. Butts and his wife, Sarah, decided to try the vaccine. "It's been much easier than chemotherapy," Butts said. "Fatigue has been my biggest problem." Only a week has passed since Butts had the first injection, but he said he hopes to get treatment for the next year. Butts said he may not have made it this far without the support of family, friends and the medical staff. Sarah Butts said she is confident that everything will work out. "We know it's not a cure," she said. "But if we could get five years, maybe there will be a cure around then."

For more about the pancreatic cancer vaccine, go to www.acctx.com.

http://theedge.bostonherald.com/healthNews/view.bg?articleid=33261

‘Super’ vaccine on tap By Kay Lazar Friday, June 25, 2004

Hoping to ease kids' trauma - and the number of time-consuming trips to the doctor - the state will make a new five-in-one childhood vaccine available free of charge at doctors' offices starting July 1. ``If you ever had a child and had to hold him down while he's getting shots, it's a painful thing, probably more for the parent than the child,'' said Christine Ferguson, commissioner of the state Department of Public Health.

With children needing up to 23 shots by the age of 2, the new five-in-one Pediarix will eliminate up to six shots from the complicated immunization schedule. Pediarix contains vaccines to guard against diphtheria, tetanus, pertussis, hepatitis B and polio.

For years, the state has funded vaccines, while private insurers pay doctors to administer them. Facing tight financial times, the state considered sharply cutting the program earlier this year. But state lawmakers last week approved a $24.8 billion budget that boosts funding for vaccinations and Gov. Mitt Romney [related, bio] is expected to approve that increase. ``We were planning to bring Pediarix online in January but we couldn't because we weren't sure of the fiscal situation,'' Ferguson said. ``We're now in the position to be able to offer parents the choice.''

CHICAGO -- This week, a series of public forums on a program requiring all pregnant women and children through age 18 years to be tested for mental health needs is being held this week in five different locations statewide.One group of parents learned about the state's plans to proceed with this program and on Monday issued an alarm asking for parents and citizens concerned about the new program to voice their opinions at the forums."We're moving toward social training over academic training with this program," Larry Trainor, a Mt. Prospect parent of four children and a contact for Citizens Commission on Human Rights, based in Los Angeles, said today. "Since psychiatric involvement in education, SAT scores have gone down for the past few decades. Evaluating mental conditions is not based on scientific evidence, it's subjective," he said.

The $10 million plan for the setup of the Children's Mental Health Act of 2003 is being considered at this week's public forums starting Monday, July 18 in Champaign. Signed into law, the bill passed the Illinois General Assembly last spring, sponsored in the House by State Representatives Julie Hamos (D-Evanston) and Patricia Bellock (R-Westmont). State Senator Maggie Crotty (D-Oak Forest) and Susan Garrett (D-Highwood) shepherded the legislation through the Senate. The legislation passed the House with a 107 to 5 vote, and the Senate unanimously. "What if they find a student has a math disorder, a reading disorder. Would that be a mental health disorder, one that would cause the parents to put their children with a drug for a condition they may or may not have?" Trainor asked.The mental health program will develop a mental health system for "all children ages 0-18 years," provide for screening to "ensure appropriate and culturally relevant assessment of young children's social and emotional development with the use of standardized tools."Also, all pregnant women will be screened for depression and thereafter following her baby's birth, up to one year. Follow-up treatment services will also be provided.Trainor said that he is trying to get parents and citizens out to voice their opinion about the new program.

Apparently, children's mental health will be assessed along with their academic standards in the new proposed testing. The Illinois State Board of Education has been given the responsibility to develop the appropriate tests, according to last year's legislation.The Task Force hosting the public forums this week are to send a recommendation to Governor Blagojevich by the end of the summer, according to the Act (HB 2900).

WASHINGTON, June 29 (UPI) -- Drug companies that have participated for decades in a federal program to stockpile children's vaccines are considering withdrawing because new accounting guidelines require them to delay booking production payments as revenue until the drugs are removed from the stockpiles for use, United Press International has learned.

The shift could mean a delay of up to a year in recognizing revenue from the contracts, potentially hurting officially reported profits and earnings per share and, by extension, stock prices. All four major vaccine manufacturers -- Aventis of Strasbourg, France; GlaxoSmithKline of London; Merck & Co. Inc. of Whitehouse Station, N.J., and Wyeth of Madison, N.J. -- are publicly traded. The problem is serious enough that Aventis, one of the world's largest vaccine manufacturers, already has told the Centers for Disease Control and Prevention in Atlanta it will not extend a stockpile contract.

"We are unable, because of the financial issues ... to proceed until this is resolved," Christine Grant, Aventis vice president for public policy and government relations, told UPI. CDC officials are worried other firms might back out as well. "It is definitely a concern," said Dr. Stephen Cochi, acting director of the CDC's National Immunization Program. The agency has maintained stockpiles of selected childhood vaccines since the 1980s. These caches enable public health officials to respond to sudden outbreaks of illness, bridge disruptions in supplies and reduce the cost of vaccinations through negotiated purchases. The CDC recently tapped into the reserves to help the Marshall Islands deal with an outbreak of measles.

Not all vaccines are stockpiled, however, and over the past four years the United States has suffered chronic shortages of vaccines needed to prevent diphtheria, tetanus, measles, mumps and meningitis. Some children went without. After an investigation, Congress ordered the CDC to expand the existing program to include all routinely recommended pediatric vaccines. The original program was aimed mainly at disadvantaged children, but the new stockpiles would be large enough to fulfill the entire county's needs for six months. The agency spent some $168 million on the effort in fiscal year 2003 and will spend approximately $680 million more by the end of FY 2006.

The accounting issue, however, threatens the expansion effort.

"This problem needs to be solved," Cochi said. "It's the main obstacle to our proceeding successfully, to have a six-month stockpile of all the pediatric vaccines by 2006/2007. It's the only major obstacle to that." The controversy centers on how the stockpiles are managed. To reduce chances of spoilage during shipment, the CDC established arrangements years ago to pay manufacturers to store the vaccines near where they are made. The stockpiles are maintained and constantly replenished by the companies.

Replenishment takes place gradually as the vaccines are sold and/or distributed. Manufacturers are allowed to remove and sell older doses of vaccine well before their expiration dates, putting one new dose in for every older dose taken out. Some vaccines are supplied free of charge under the Vaccines for Children program. The stockpile is continually refreshed as doctors and public health programs are supplied, explained Kimberly Lane, associate director of management and operations for the CDC's National Immunization Program. Few if any doses are thrown away.

The approach has been regarded as routine and beneficial by both the manufacturers and the CDC. There also has been no dispute over when the firms are paid. "We pay them upon on delivery into the stockpile. We pay them for everything in full, up front," Lane said. "We (also) pay them a separate fee just to rotate that product and keep it fresh." In December, however, the Securities and Exchange Commission, which has the last word on accounting questions, codified official guidance on how to handle such "bill and hold arrangements," as the transactions are called. The update affected SEC Staff Accounting Bulletin 101, which officially was issued in 1999.

Auditors now are telling drug companies they cannot count payments for the vaccines as revenue until the vaccines actually are taken out of the stockpile for use -- a delay that could be as long as a year. Though they still have the cash in hand, delays in counting the cash as revenue can put firms in a bind. "If you store a product for the U.S. government, and for whatever reason the U.S. government does not take title to that, under the accounting rules you can't recognize the revenue for that," Kim Bush, president of the Vaccines Business Unit of Baxter Healthcare Corp., in Deerfield, Ill., told experts on vaccine finance at a meeting in Washington this week.

"Whether a company gets to recognize revenue immediately or not ... is going to have a direct impact on the bottom line profits," said Dan Noll, director of accounting standards for the American Institute of Certified Public Accountants. "That means, for example, that a very common measure that investors look at, earnings per share, will be directly impacted as a result of whether the company can record the revenue up front or not." "Our concern now," Grant said, "is (that), after several decades, this new SEC guidance document says that when you enter into a contract for a new stockpile, or get an amendment for or renew an old stockpile you, our auditors say, can no longer report what the government actually pays you."

The reason for the shift is unclear, but it might be rooted in increased scrutiny of revenue transactions after recent corporate scandals. "In general, a large number of restatements that were forced by the SEC were because of revenue matters," said Noll. An SEC spokesman declined to comment on the matter and said opinions are expressed solely through the precisely worded materials issued officially by the SEC.

"We don't speak beyond the document," he told UPI. The firms have met with SEC officials to express their concern and Congress is now getting involved. "Senator Harkin is looking at (the issue) and seeing if there is any way to resolve this, said Maureen Knightly, communications director for Iowa Democrat Tom Harkin. None of the government or company officials who spoke to UPI, however, were clear on how the problem could be solved. The SEC rules are not aimed specifically at vaccine manufacturers, but are general guidance for all companies. Any changes could have far wider impact than intended.

One suggestion is to have the CDC take possession of pediatric stockpiles. The agency plans to take possession of smallpox and anthrax vaccine stocks being created to deal with potential bioterrorism attacks, said Bush, of Baxter Healthcare, which will prevent firms working on those stockpiles from having to deal with the delayed revenue issue. Should the CDC take possession, however, the agency could end up facing commerce-like problems of inventory control, sales and shipping -- matters now handled by the manufacturers.

"This is something that is actively being worked on and needs to be fixed," said Lance Rodewald, director of CDC's Immunization Services Division. "(It) has to be fixed because right now it really does get in the way of our being able to build up the stockpile. I am confident it is going to be resolved but it has not been resolved yet."

If you go to a doctor, you want them to know your medical history. That includes your records from other doctors. But some parents in the Coastal Empire have had trouble getting their children treated or in school because they can't get those records. Parents say with little notice, their doctor closed up shop, and without records they must start from scratch.

On the first day of school, four-year-old Hannah Berry is less than excited. When her mother brought her to Glennville Elementary this morning, she says her arms were still swollen from vaccinations she's now had twice. "For her father and me, it's upsetting watching her go through all this unnecessarily because if we had the records she wouldn't have to go through it," said Tara Berry.

They and other parents say they can't get their children's medical records from Dr. William Morrissey. They claim they've been trying since he closed his Hinesville practice in March.

For years, Carol Jarrett swore by the pediatrician. Now she'd like the chance to swear at him. "I'm not trying to hurt him as a person," she told us. "He was a good doctor and this just isn't his character."

The attempt to get records is especially trying for parents of special needs children or some who've undergone surgery this summer. "My new doctor is treating Dakota blindly," said mother Crystal Stanfield. "He only has what I've told him is wrong with him. He really needs to see that stuff for himself."

For little Hannah, it's not over yet. "Every four weeks, we'll have to go in for more shots until she catches up, which I'm not sure how many that is," her mother told us.

Parents say they just want what they feel is theirs already. The parents we spoke with say they've tried directly and through their new doctors to get records, all with no luck. We've tried since Friday afternoon to get Dr. Morrissey through his new employer and had no luck as well.

Georgia State University's Biosafety Level (BSL)-4 lab is one of five biomedical research facilities in the United States devoted to the study of the world's deadliest pathogens. The lab, located in downtown Atlanta, concentrates its efforts on the study of herpes B, a virus common to some monkeys though rare in humans. But human contagion is not unheard of, usually among workers at primate labs who get bit or scratched by monkeys, and is lethal if not treated early. The other labs are part of a federal system developing ways to combat emerging infectious diseases and preparing for a potential bioattack, each with numerous researchers trying to create diagnostic tests, treatments, and vaccines. The government is pushing ahead with plans to build more BSL-4 labs at the Fort Detrick Army complex in Maryland and in Galveston, Texas; Hamilton, Mont.; and Boston, where the plans have met with stiff opposition from community activists and a group of 150 scientists, including two Nobel Prize winners, who question the wisdom of building such a site in an urban landscape

Babies as guinea pigs. Whooping Cough Vaccine

Ivanhoe Broadcast News NASHVILLE, Tenn. (Ivanhoe Broadcast News) -- Pertussis or whooping cough has been called the hundred-day cough because it can last that long. After a vaccine was developed in the 1940s, the number of cases dropped, but now it's rising with as many as 8,000 cases a year. In infants, it can be fatal. Here's what's being done to protect more babies from the disease.

Four-month-old Hamp Morris visits the doctor today, but his appointment is special. Hamp is part of a clinical trial that's changing his vaccine schedule. Normally, a baby starts their series of three whooping cough vaccines at two months. Hamp got his first dose when he was born. "We are glad to be in this study," says Hamp's mother, Anne Marie. "We are glad to be helping and glad that we can be part of something that might help children, especially later down the line." Pediatrician Natasha Halasa, M.D., says whooping cough is highly contagious. If infants catch it from an adult, it can turn deadly. That's why the earlier they start to be protected, the better.

"Kids could actually mount an immune response and get their second vaccine by two months of age, protecting them earlier, instead of waiting until four months, where they get the second shot," Dr. Halasa, of Vanderbilt Children's Hospital in Nashville, Tenn., tells Ivanhoe. It happened to 9-month-old Blayne Sands. When he was 5 weeks old, he got whooping cough and stopped breathing for 21 seconds. Blayne's mom, Starla, says, "You just cannot explain the fear, the emotion you go through, the helplessness." She says, while it's hard to talk about what happened to her son, she feels it's important to tell parents to take this disease seriously. "If it is an adult-sounding cough, and they are gasping for air, they need to be checked out," she says. Like many babies, Hamp is not happy about his vaccines. What he doesn't realize is that the study he's involved in could save babies in the future from a dangerous disease. There are two other options being considered to decrease the number of whooping cough cases. Researchers are looking at vaccinating women while they are pregnant or to add another vaccination during the adolescent years. This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/. If you would like more information, please contact: Carole Bartoo Public Relations Manager Vanderbilt Children's Hospital 2200 Children's Way, Suite 2515 Nashville, TN 37232 (615) 322-4747 http://www.vanderbilt.edu Last Updated: August 16, 2004

“I think several strategies would be good to try,” said Halasa. “Pregnant mothers given the vaccine may pass some protection on to babies, adolescent boosters would reduce the chances of adolescents or adults giving it to babies, but we’re about to study how effective it would be to give a baby’s first pertussis vaccination earlier in life… at birth.” Right now Halasa is looking to enroll 50 women who are preparing to deliver full term babies or healthy infants between the ages 2-14 days who have not yet received their Hepatitis B vaccination. In this pilot study, 25 newborns will get the normal Hepatitis B vaccine at birth, while the other 25 will get a diphtheria, tetanus and acellular pertussis (DTaP) vaccination along with their Hepatitis B vaccine, that’s two months before the normal schedule to begin vaccination for pertussis.

The main purpose of this study is to determine if it is safe to administer an additional dose of the pertussis vaccine in the first days of life and also to see if babies can mount an adequate immune response. If it is successful, Halasa hopes an eventual change in the immunization schedule might save babies’ lives.

For more information on the study email NPVstudy@vanderbilt.edu or Call Alice O’Shea at 343-8518.

http://www.aidsmap.com/en/news/7C32EE0F-7FAD-4B44-BE69-5DEDE586E8AC.asp Julian Meldrum Thursday, September 02, 2004 In two separate presentations at the AIDS Vaccine 04 meeting in Lausanne, Dr Frederic Tangy from the ANRS in Paris advocated the use of a licensed live attenuated measles vaccine – the very same one used in the MMR system given to millions of children – as a vehicle to deliver an HIV vaccine for future generations. The proposal marked a welcome shift in the direction of serious consideration of how to make future HIV vaccines available to infants and adolescents – especially girls - who are, in many countries, the populations most desperately in need of protection against the epidemic. A Swiss company, Berna Biotech, has already made prototypes based on a live measles vaccine with HIV genes inserted, and a progress report on this work was also presented.

The vision would be that a child would be vaccinated from before the age of one and boosted at around the age of 10 to achieve a level of immunity that could and should last until adulthood. Adults with pre-existing immunity to measles – or at least those who have been previously vaccinated – could either receive repeated doses of measles-based vaccine or a prime-boost using measles with another vector, both containing HIV-related sequences.

The arguments put forward in support of this strategy include the excellent safety record of this live vaccine, its remarkable ability to offer long-term and boostable protection against disease, and that large-scale manufacturing facilities in several countries produce tens of millions of doses at extremely low cost. By inserting HIV-related sequences in one or more of three distinct locations in the vaccine strain, immunity to HIV could be induced in addition to protection against measles at no extra cost.

There are, however, one or two problems identified in the course of the meeting.

The first difficulty is that no-one knows precisely what components of HIV, and in what form, should be included in such a vaccine. The very long-acting effect of the measles vaccine could itself generate serious problems, if the wrong elements were added to it. At worst, children vaccinated in infancy might have inappropriate immune responses and would be unable to benefit as adolescents from a better vaccine that might by then be available to them.

The second problem is that the idea of using an established vaccine in this way would need to be discussed and agreed with stakeholders who are not currently involved in the AIDS vaccine effort and were not represented at the meeting in Lausanne. Given that millions of children in developing countries are still dying each year from measles, nothing should be done that could in any way undermine public confidence in the vaccine programme.

Measles is far from being eradicated, and mass vaccination with the live vaccine is therefore likely to continue for decades to come. However, the same is hopefully not the case for polio.

Some researchers would like to include HIV antigens in a version of the currently licensed live Sabin polio vaccine.They point to animal studies in which polio-vectored SIV components have been one of the very few systems shown to protect monkeys against some particularly virulent forms of SIV. The only comparable protection has been achieved with live attenuated forms of SIV itself, which is unacceptable as a prototype for HIV in the light of evidence that such viruses do, eventually, cause SIV-related disease.

This proposal flies in the face of moves in countries such as the UK to abandon live polio vaccine in favour of less potent but non-replicating vaccines given by injection. If the politics and other circumstances of the last refuges of the virus in Africa and Asia allow polio to be eradicated, will anyone really want to continue to use live polio vaccines? Those vaccines can – at a rate of less than one in a million – revert to forms that cause damage to the nervous system. It is claimed that with “high fidelity” variants of a key enzyme, this risk can be reduced. But since the only way to prove this would be through giving the vaccine to millions of people, will anyone ever be prepared to make the experiment, at the risk of re-introducing polio in a world where immunity to the disease would be waning fast?

HEALTH chiefs have taken on a specialist nurse to ensure that more parents take their children for the MMR jab. Fewer people are presenting their children at surgeries in Chorlton, Fallowfield and Whalley Range for the vaccine as compared with the rest of south Manchester. And medical staff say apathy and lingering fears that the jab has links with autism mean 20pc of parents are not taking up the service. The government says that figure should be no more than five pc in all areas of the country.

Anne Shepherd, 41, has been employed as the new Immunisation Awareness officer at Central Manchester Primary Care Trust and has a remit to increase rates for the take-up of both the MMR jab and the latest winter flu vaccine. She said: "Some people may have read a fragment in a newspaper about MMR and instead of getting more information they have decided against having it. "It’s a question of rebuilding confidence. Some people are complacent because they don‘t see anyone suffering from the diseases. What they don‘t realise is that measles and mumps can lead to meningitis or acquired deafness. In certain circumstances they can be fatal."

Anne is now helping health clinics and surgeries chase down those families who have failed to respond to NHS reminders about MMR. She is even preparing to ‘mug’ mums at nurseries with syringe in hand and has even held MMR ‘parties’ with free food and drinks to entice families along. She added: "Some people have made a choice, others find there are more pressing issues in their lives. One woman told me she’d been on holiday and thought she’d missed her chance."

Families who have failed to respond may receive a telephone call from Anne Shepherd or GPs’ surgeries.

Call to Action: Seniors for Childhood Immunizations

W. Seventh Ave. Amarillo, TX 79101

Seniors for Childhood Immunizations needs volunteers 55 or older to visit new mothers in the hospital to inform them of the importance of vaccinating their babies. Volunteers will hand out packets and register mothers to receive reminder cards of shot dates. Contact Larue Johnson at 373-8389.

Call to Action is an effort to match volunteers with agencies in need of assistance. Agencies can submit requests for assistance to be published in the Amarillo Globe-News by calling the United Way Volunteer Action Center at (806) 373-2662, faxing them to (806) 345-7981 or e-mailing them to vac@unitedwayama.org.

Last year, the flu shot didn't work so well. It's estimated that half the adults who came down with flu had first gotten the shot.

This year, some flu vaccine is contaminated. When discovered in August, U.S. officials promised it was no big deal. They were undercut this week by the British, who, citing bacterial contamination, shut down a plant that makes half our vaccine supply.

Now imagine, amid this mess, that your employer comes to you and says: "Get a flu shot or you're fired." That's the predicament faced by 5,000 workers at Seattle's Virginia Mason Medical Center. They have until Jan. 1 to get the shot, or get canned. It's believed to be the first hospital in the nation to require flu vaccines. In doing so, it pits two ethical principles central to the practice of medicine against each other. The Hippocratic Oath says "do no harm." The hospital argues that vaccinating everyone reduces the chance a sick doctor or nurse will give the flu to vulnerable patients.

That seems reasonable. But it's also up to patients whether to accept any medical care, from surgery to drugs. Typically patients — in this case, the staff — are free to assess the risks and benefits, and decide what is injected into their bodies, without being threatened. The union representing the hospital's 600 nurses filed suit last week against the mandatory shots. Like most ethical conundrums, this one has no easy answer. In this case, though, I side with the nurses.

The reason? Our nation's flu program is in shambles.

We're being treated to a press frenzy this week about how citizens allegedly are panicking to get their flu shots before supplies run out. But I'd argue the opposite: Unless you're in one of the high-risk groups, who would want one?

Consider the nation's medical professionals. They talk unceasingly about how everyone should get shots. But they don't follow this advice themselves. Only 36 percent of America's health-care workers get vaccinated — about the same rate as the rest of us, according to the U.S. Centers for Disease Control and Prevention. In their court filing, the nurses go so far as to allege that requiring flu shots violates the hospital's duty "to maintain a safe and healthy workplace." They contend the shots pose risks, and that the hospital's backup plan — antiviral medicine — is even worse because those medicines have "significant side effects."

Add to that the constant problems with the vaccine supply and its spotty record at warding off flu. It hardly inspires confidence, does it?

I'm not saying the flu shot is categorically bad. It's one of the safer vaccines, and vulnerable people, such as the elderly, should consider getting it. Even if Virginia Mason ends up backing away, its policy is part of a movement toward "universal vaccination." The idea is that the only way to beat the flu for anyone is to give shots to everyone. Until healthy, intelligent doctors and nurses are willing to take the shot without being forced, count me out.

Danny Westneat's column appears Wednesday and Friday. Reach him at 206-464-2086 or dwestneat@seattletimes.com.

http://www.freep.com/news/health/polio19e_20041019.htm

"Repeated visits by vaccinators every six to eight weeks gnaw at some parents' patience. Some children have swallowed the vaccine 20 times; at most, six or seven doses are needed to immunize a child. International health officials insist that overuse of the vaccine isn't harmful."

Did you wonder why so much attention has been devoted to reporting whooping cough outbreaks? To scare you into the new vaccine!

(WebMD) An experimental whooping cough booster shot called Boostrix may help stamp out the infection, a new study shows.

If approved by the U.S. Food and Drug Administration, Boostrix could be added to a booster shot, which boosts the immune system’s protection against diphtheria and tetanus.

In a clinical trial of more than 4,000 healthy youth aged 10-18, Boostrix was as safe and effective as the current diphtheria vaccine. It also triggered a greater immune response against whooping cough than that seen in infants who had received the primary immunization for diphtheria-tetanus-pertussis and were protected against pertussis. The vaccine’s maker, GlaxoSmithKline, conducted the study. The company is also a WebMD sponsor.

Diphtheria, tetanus, and pertussis (whooping cough) are bacterial infections that cause serious illness. Vaccination, given as a series of injections during childhood, helps protect against these illnesses. But older children, adolescents, and adults still require boosters of protection against these illnesses. These boosters are given at ages 11-12 and every 10 years for diphtheria and tetanus.

However, many people may be surprised to learn that whooping cough can be a problem for adolescents.

The current vaccine recommendations call for the pertussis vaccine to be given to children in a series of five doses, ending by age 6. However, results usually last about five to10 years after the last dose is given, which can leave teens vulnerable. Leonard Friedland, MD, of GlaxoSmithKline, and colleagues reported their findings in Washington, at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy. In the last 20 years, whooping cough diagnoses have nearly tripled, despite the fact that more babies and young children are getting the pertussis vaccine. Better diagnostic methods may partially account for the increase, but a rise in cases among adolescents and young adults has also occurred.

Whooping cough is usually not a life-threatening illness in teens and young adults. However, its symptoms can last for months, interrupting daily life, and threatening to infect other people. The highly contagious infection can cause severe coughing spasms that sometimes make it difficult to eat, speak, or breathe. In 2003, there were 11,000 cases of whooping cough reported to the Centers for Disease Control and Prevention. That’s the highest number in nearly 40 years, according to a GlaxoSmithKline news release. Of those 11,000 cases, 40 percent occurred in people aged 10-19, according to the CDC.

Poor families may join just to get the perks, staff fears. Washington - An Environmental Protection Agency proposal to study young children's exposure to pesticides has sparked a flurry of internal agency protests, with several career officials questioning whether the survey will harm vulnerable infants and toddlers.

The EPA announced this month that it was beginning a two-year investigation, partially funded by the American Chemical Council, of how 60 children in Duval County, Fla., absorb pesticides and other household chemicals. The chemical industry funding initially prompted some environmentalists to question whether the study would be biased, and some rank- and-file agency scientists are now questioning whether the plan will exploit financially strapped families.

In exchange for participating for two years in the Children's Environmental Exposure Research Study, which involves infants and children up to age 3, the EPA will give each family using pesticides in their home $970, some children's clothing and a camcorder that parents can keep.

EPA officials in states such as Georgia and Colorado sent e-mail messages to each other last week suggesting the study lacked safeguards to ensure that low-income families would not be swayed into exposing their children to hazardous chemicals in exchange for money and high-tech gadgetry. Pesticide exposure has been linked to neurological problems, lung damage and birth defects.

Suzanne Wuerthele, the EPA's regional toxicologist in Denver, wrote to her colleagues on Wednesday that after reviewing the project's design, she feared poor families would not understand the dangers associated with pesticide exposure.

"It is important that EPA behaves ethically, consistently, and in a way that engenders public health. Unless these issues are resolved, it is likely that all three goals will be compromised, and the agency's reputation will suffer," she wrote in an e-mail obtained by the Washington Post. "EPA researchers will not tell participants that using pesticides always entails some risk, and not using pesticides will reduce that risk to zero."

Troy Pierce, a life scientist in the EPA's Atlanta-based pesticides section, wrote in a separate e-mail: "This does sound like it goes against everything we recommend at EPA concerning use of (pesticides) related to children. Paying families in Florida to have their homes routinely treated with pesticides is very sad when we at EPA know that (pesticide management) should always be used to protect children."

Linda Sheldon, acting administrator for the human exposure and atmospheric sciences division of the EPA's Office of Research and Development, said the agency would educate families participating in the study and inform them if their children's urine showed risky levels of pesticides. She said it was crucial for the agency to study small children, because so little is known about how their bodies absorb harmful chemicals.

"We are developing the scientific building blocks that will allow us to protect children," Sheldon said, adding that the study design was reviewed by five independent panels of academics, officials of the Centers for Disease Control and Prevention, and representatives of the Duval County Health Department.

Families can remain in the study, even if they stop using pesticides, Sheldon said, as long as they were using them before the experiment started. It was unlikely that any family would volunteer for the study out of financial need, she added, because researchers will require parents to invest time in monitoring their children's activities and diet.

"Nobody can go into this study just for that amount of money," Sheldon said.

R. Alta Charo, a professor of bioethics at the University of Wisconsin at Madison's law and medical schools who co-wrote a National Academy of Sciences report last year on the use of pesticides for research, said EPA officials were struggling with how to balance the need to protect the individual child's interests against the goal of pursuing a broader scientific agenda. While she said the agency's approach was reasonable, Charo said it does raise ethical questions.

"Where is the line between enticement and a godfather offer" that impoverished families would find hard to refuse? Charo said. "That is really troubling. We make these decisions over and over in public policy. This is one of those moments."

Several EPA officials, all of whom asked not to be identified for fear of retaliation, also questioned why the agency removed the study design and its recruitment flyer from the EPA's Web site once some scientists started to complain about the project. Sheldon said the agency is rewriting how it portrays the research.

"We removed it so we could modify it, so it would make more sense," she said.

Good News!!

We are gratified to inform you that the EPA has suspended a pesticide experiment in which would have exposed 60 babies to the hazards of pesticides-rather than educating the public about the hazards pesticides pose for children. The purpose of the cynically named experiment, CHEERS, was to study how children absorb poisonous chemicals.

The EPA alloted $7 million of taxpayer money and accepted an additional $2million from the American Chemical Council.

A similarly unethical experiment which was co-sponsored by the EPA exposed young children to lead poison-without any effort to prevent harm. In a landmak decision, the Maryland Court of Appeals ruled that exposing children to any risk above minimal risk in non-therapeutic experiments was unethical and violated fundamental moral principles. The Court ademonished the research community for approving such research to be conducted on helpless children. Check the AHRP website for a link to the court decision and to AHRP's amicus curiae brief in support of the Court.

(we are in the process of upgrading /updating our website, so if you don't find it, try again) We applaud Juliet Eilperin of The Washington Post for her coverage bringing public attention to the experiment. http://www.washingtonpost.com/wp-dyn/articles/A10728-2004Oct29.html http://www.washingtonpost.com/ac2/wp-dyn/A62569-2004Oct25?language=printer <http://www.washingtonpost.com/> Contact: Vera Hassner Sharav 212-595-8974 veracare@ahrp.org

The Environmental Protection Agency has suspended a controversial study aimed at exploring how infants and toddlers absorb pesticides and other household chemicals, officials said yesterday.

Several rank-and-file EPA scientists had questioned the ethics of the two-year experiment, which would have given the families of 60 children in Duval County, Fla., $970 each as well as a camcorder and children's clothing in exchange for having the children participate. The critics said low-income Floridians might continue to use pesticides -- which have been linked to neurological damage in children -- in their homes to qualify for the project. Environmentalists had also criticized the study because the industry-funded American Chemistry Council had agreed to pay $2 million of the project's approximately $9 million cost.

EPA spokeswoman Cynthia Bergman said officials had asked a group of independent experts to reexamine the study design, which has already been reviewed by several independent panels of academics, officials of the Centers for Disease Control and Prevention, and representatives of the Duval County Health Department. The new panel is set to give the EPA its assessment next spring.

"Since the study was announced last month, many have raised concerns, including scientists within EPA. We want to be responsive to those concerns," Bergman said. Jeff Ruch, executive director of Public Employees for Environmental Responsibility, said, "Regardless of the number of reviews, paying poor parents to dose their babies with commercial poisons to measure their exposure is just plain wrong."

Administration and industry officials said it was important to pursue the study to give regulators better information on how harmful chemicals get into children's bodies. At the American Chemistry Council, spokeswoman Marcia Lawson said the group "continues to strongly support the study because of the great importance of increasing understanding of the exposures of young children to pesticides and other chemicals they naturally encounter in their daily lives."

College, a petri dish for mumps Health officials focus on vaccinating young adults after an outbreak among students. By Melissa Healy, Times Staff Writer April 24, 2006

When Iowa college students early this year began turning up in doctors' offices with puffy necks, headaches, fevers and, among some young men, swollen testicles, many physicians missed a diagnosis most doctors could have made in their sleep 25 years ago. These patients had the mumps — as do at least 1,100 in eight Midwestern states as of Friday. The outbreak is still unfolding, spreading east and west, and beyond the 18- to 25-year-old set.

Their affliction was missed by many physicians unaccustomed to seeing — especially in college students — a childhood disease largely quashed by widespread vaccination in the 1980s. Now public health officials are trying to understand how this disease, which in rare cases can cause deafness, encephalitis and male sterility, could have regained a foothold in the U.S. after so many years.

The Midwest mumps outbreak has been all the more surprising because it has largely affected the first generation of young adults to have commonly had not one, but two doses of the vaccine that protects against measles, mumps and rubella. Double vaccinations, widespread since a 1989 outbreak of measles, were thought to confer complete mumps immunity to about 90% of recipients.

Experts suspect two factors: spotty vaccination coverage among college-aged kids and the unique bacterial and viral mixing bowl that is dorm life. The virus that causes mumps appears to have found its perfect home in the college scene — with multiple kids lolling on beds in great heaving groups, swigging drinks in common, kissing and cruising the bars even when they're sick, and — oh, yes — attending classes en masse.

"They eat after each other, drink after each other, share other personal items — we know that living under those settings, people run higher risks of infection," says Dr. Georges Benjamin, executive director of the American Public Health Assn.

Health experts say the outbreak should help focus new attention on the need to vaccinate adolescents against a growing variety of diseases before they leave the nest and dive into this unique germ pool.

The U.S. military ensures comprehensive vaccinations for new recruits. Given its unique powers of enforcement, coverage is virtually universal there. But on campuses, lax rules and even more casual living arrangements provide ideal conditions for the spread of germs. On many college campuses, vaccinations are recommended but not mandated. Waivers are granted — ostensibly on health or religious grounds — liberally.

A call to change this state of affairs has been building steadily, fueled by the development and approval of a raft of new vaccines designed for youths between 10 and 18 years of age.

In February 2005, the Centers for Disease Control's Advisory Committee on Immunization Practices recommended that all teens — especially those about to enter college dorms — receive a new vaccine against meningococcal disease, which can cause meningitis and lead to brain damage; loss of hearing, eyesight or limbs; and death.

The CDC's advisory committee has also recommended that all adolescents get a booster of a new tetanus, diphtheria and pertussis (or Tdap) vaccine that protects against the bacterial infection pertussis, also called whooping cough. Whooping cough cases have been on the rise across the nation, especially among young adults.

In the next few years, additional vaccines aimed at teens are expected to win Food and Drug Administration approval, making it likely that young adolescents will have a list of recommended immunizations almost as long as the preschool set. Among the vaccines moving through the pipeline are ones to protect against sexually transmitted diseases such as human papilloma virus — a principal cause of cervical cancer — as well as chlamydia and gonorrhea.

In the coming years, vaccines that would protect against the herpes simplex virus (which causes fever blisters and genital sores) and the respiratory syncytial virus (which causes flu-like respiratory illness) are also expected to be recommended for children 12 to 18 years old.

Roughly half of the states, including Iowa, do not have precollege vaccination requirements in place, according to Dr. Jane Seward, acting deputy director of the CDC's viral diseases division.

Such rules are typically left to colleges to enforce, and where state rules are absent, colleges and universities are left to adopt regulations on their own. "It's more rigorous at some schools than others," says Victor Leino, research director of the American College Health Assn.

The result: When students at a college in Dubuque, Iowa, returned to homes across the Midwest for winter break, they brought with them the highly contagious mumps virus, as well as their own vulnerability. In fewer than five months, the outbreak spread to Kansas, Nebraska, Minnesota, Missouri, Wisconsin and Indiana. It's expected to move next toward Arizona and the Eastern Seaboard.

Seward said that many heads of state and territorial public health agencies were confronting for the first time a gap in their state vaccination requirements at the crucial college entry point.

"They're certainly going to be thinking about that" now, she added.

But if teen vaccinations are the immunization community's next big push, health officials have their work cut out, says Dr. Robert S. Lawrence, a dean at Johns Hopkins Bloomberg School of Public Health.

Unlike preschoolers, whose parents drive them to yearly check-ups, adolescents are less likely to see a physician for routine physicals, more likely to reject a shot when they feel fine and often not covered for preventive healthcare. Adding to the problem, parents of teens often think childhood vaccinations should have been enough and have less power to persuade their older children to get immunized.

"Teens are pretty unresponsive in general — they tend to believe that they'll live forever and don't need these things," says Lawrence, who led a study by the Institute of Medicine of future U.S. vaccine priorities.

To get around this problem, some experts have suggested making immunization a requirement for getting a driver's license — a powerful lever of enforcement that would cover college-bound kids as well as those who move into the job market.

"It's very hard to capture this group of kids," says Benjamin. He recently learned this firsthand as one of his own kids got ready to go off to college.

Excited to get her school experience underway, his daughter was a little too eager to sign a college release form waiving the need for immunization with the new meningococcal vaccine.

"I had to suddenly become a more firm parent," says Benjamin. "The last thing I want is for my child is to die from a vaccine-preventable disease

Vaccination clinics at polling sites Free shots given to those 50 and older in East End, North side Voters 50 and older will have another choice to make when they head to the polls. They can decide to protect themselves for the winter by getting a free flu shot at one of the vaccination clinics set up by the Houston Department of Health and Human Services and Amerigroup Foundation at four polling sites. The "Vote & Vaccinate" clinics will be set up from 9 a.m.- 4 p.m. today through Friday, Nov. 3, at: •Sunnyside Multi-Service Center, 4605 Wilmington •Acres Homes Multi-Service Center, 6719 W. Montgomery •Moody Park, 3725 Fulton •Ripley House, 4410 Navigation. Voters will need to present any official document proving that they are at least 50 years old to receive a flu shot. HDHHS and Amerigroup secured 3,000 doses for the initiative, sponsored for the first time in Houston through funding from the Robert Wood Johnson Foundation. Houston is one of 25 cities nationwide sponsoring the Vote and Vaccinate clinics. The four polling sites with vaccination clinics are located within Hispanic and black communities. National studies by the Centers for Disease Control and Prevention indicate that blacks and Hispanics have the lowest influenza vaccination rates when compared to other ethnic groups. The CDC recommends that all Americans age 50 and older receive annual flu shots to help limit the spread of the influenza virus. Elderly people are particularly vulnerable to the disease, which kills more than 32,000 people over age 65 every year. Caused by different viruses, the flu is a contagious disease that results in symptoms such as fever, headache, tiredness, cough, nasal congestion, sore throat and body aches. Most people recover in one to two weeks, but some develop complications such as pneumonia, bronchitis and sinus and ear infections. Details: 713-794-9267. Park Officials Try Birth Control Method To Curb Squirrel Population

March 7, 2007 9:04 p.m. EST

Nidhi Sharma - All Headline News Staff Writer Santa Monica, CA (AHN) - In a bid to control the ever-growing population of squirrels, officials at Santa Monica's Palisades Park are injecting them with birth control medicine. The squirrels will be injected with an immuno-contraceptive vaccine meant to stunt sexual development as a form of birth control.

The officials decided to opt for this method of birth control after other methods like euthanasia; poison or gassing failed to control their population. There are around 1,000 squirrels in the Park that can be aggressive and dangerous to the health of people they come in contact with.

SF Gate quotes Joe McGrath, the city's parks chief as saying, "We don't want to kill them if we don't have to. I personally like squirrels, but we also have to be receptive to the county's concerns."

Squirrels are possible carriers of rabies, or fleas, which could carry diseases like bubonic plague. The new vaccine that stops lactation and ovulation in females and testicular growth in males has no side effects. Berkeley is the only other city to try this method, which was developed by the U.S. Dept. of Agriculture. It comes at a cost of $2-$10.

FREDERICK, Maryland (CNN) -- Andrew Stein, 10, and his brother, Nathan, 7, are having a typical end-of-summer vacation: hanging out at the pool, visiting their grandparents and waiting for the beginning of school.

But this week they're doing something most of their classmates will never do. The Stein brothers will be testing the new vaccine to prevent swine flu. Because the younger population, from 6 months to 24 years, is at high risk of developing complications from the H1N1 virus, the National Institutes of Health is conducting a clinical trial specifically to make sure the vaccine is safe for children. Vaccine developers hope to get the doses out by mid-October, before the flu season really shifts into high gear.Although both boys dislike needles, they are willing to make the sacrifice. "One boy that I knew at our school died from a type of the flu," said Andrew, frowning. "So I wanted to prevent that as much as I could."

The boys, who live in the suburbs between Baltimore, Maryland, and Washington, got their first inoculations at the vaccine satellite office in Frederick, Maryland. The trial is being conducted by the University of Maryland School of Medicine, one of 11 institutions across the country holding pediatric trials. Researchers will test the boys' blood, have them keep journals and make sure they have no severe reactions after each vaccine. The pediatric studies are divided into two groups within the United States. Half the sites will be comparing reactions between the H1N1 shot and the seasonal influenza vaccines on kids; the others will be looking at the effectiveness of a two-dose vaccine. The Steins are enrolled in the dosage trial.

The data are crucial for developing a safe vaccine, said Dr. Karen Kotloff, who heads both the pediatric and adult trials at Maryland. "The purpose of the studies we are doing is to try to collect information that will help to inform policymakers about the best way to give the pandemic H1N1 flu vaccine," she said. "Whether we need one or two doses and what strength we need."Before they received their shots, both boys, along with their parents, Christy and Eric Stein, got an explanation of the procedure and were warned about possible complications. Nancy Wymer, who coordinates the study, says the boys will receive two inoculations over six weeks and will continue to check in periodically over the following six months. Neither brother gave more than a grimace as he rolled up his sleeve and took a shot for science. Andrew Stein said it was no big deal. "It was in and out, in a couple of seconds."

Why would parents have their children be part of such a trial? Most say to help other children. Christy Stein was involved in a pediatric trial for the swine flu vaccine in 1976 and understands what her sons are going through. But she also believes it's good for the country's public health. "I trust the people who are running the study," she said. "And I'm not concerned about it at all."The studies are based on other influenza trials in the past. Many parents have already volunteered their children but openings still exist. Children 6 months to 35 months are needed, Kotloff said. "Like with any shot, children may have a sore arm. Your arm can be red...There might be some fever or achiness, but the symptoms go away in a couple of days.

"There can be allergic reactions, mostly rashes, but in some rare circumstances there can be severe allergic reactions," she added. "Each volunteer is informed about these possibilities, so it's up to the parents to make that choice."The 11 main sites across the U.S, in nine states, are currently recruiting children for the vaccine trials. The two-dose vaccine tests are being conducted at the University of Maryland Baltimore; Duke University in Durham, North Carolina; Children's Mercy Hospital in Kansas City, Missouri; Children's Hospital and Regional Medical Center in Seattle, Washington; and Vanderbilt University in Nashville, Tennessee. And the trial comparing H1N1 and seasonal flu vaccines is at Hope Clinic, Emory University in Atlanta, Georgia; St. Louis University in Missouri; the University of Iowa in Iowa City; Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio; Baylor College of Medicine in Houston, Texas; and the University of Texas Medical Branch in Galveston. Each location has a Web site to sign up if more children are needed.

Andrew and Nathan are doing fine. They will keep a diary on how they feel and what, if any, reactions they have. Each was rewarded with a $40 gift card for his trouble. And even after being stuck with a couple of needles, Nathan Stein says it was worth it. "Not just for the gift card," he said, "but for being able to help other kids."

http://www.tennessean.com/apps/pbcs.dll/article?AID=201010050310

Pregnant women sought for study The Vanderbilt Vaccine Research Program is looking for dozens of pregnant women to participate in a study on the use of flu vaccine.

The research will examine the immune responses to the influenza vaccine in the mother and baby. It's safe and universally recommended that all pregnant women receive the flu vaccine. Women ages 18-39 who are in the second or third trimester of pregnancy are eligible to participate. Each woman will receive the flu vaccine and have her blood drawn four times over a six-month period.

The study will be at the Vanderbilt Center for Women's Health, 719 Thompson Lane, Suite 27100.